• Research article
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  • Published: 30 May 2013

Case studies of innovative medical device companies from India: barriers and enablers to development

  • Szymon Jarosławski 1 &
  • Gayatri Saberwal 1  

BMC Health Services Research volume  13 , Article number:  199 ( 2013 ) Cite this article

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Over 75% of the medical devices used in India are imported. Often, they are costly and maladapted to low-resource settings. We have prepared case studies of six firms in Bangalore that could contribute to solving this problem. They have developed (or are developing) innovative health care products and therefore are pioneers in the Indian health care sector, better known for its reverse engineering skills. We have sought to understand what enablers and barriers they encountered.

Information for the case studies was collected through semi-structured interviews. Initially, over 40 stakeholders of the diagnostics sector in India were interviewed to understand the sector. However the focus here is on the six featured companies. Further information was obtained from company material and other published resources.

In all cases, product innovation has been enabled by close interaction with local medical practitioners, links to global science and technology and global regulatory requirements. The major challenges were the lack of guidance on product specifications from the national regulatory agency, paucity of institutionalized health care payers and lack of transparency and formalized Health Technology Assessment in coverage decision-making. The absence of national evidence-based guidelines and of compulsory continuous education for medical practitioners were key obstacles in accessing the poorly regulated and fragmented private market.

Conclusions

Innovative Indian companies would benefit from a strengthened capacity and interdisciplinary work culture of the national device regulatory body, institutionalized health care payers and medical councils and associations. Continuous medical education and national medical guidelines for medical practitioners would facilitate market access for innovative products.

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In the case of drugs, due to its strong reverse engineering skills, India is virtually self-sufficient. In contrast, 75% of the annual purchase of devices and diagnostics comes from imports [ 1 ]. A WHO report on medical devices pointed out that: “almost all devices present in developing countries have been designed for use in industrialized countries” [ 2 ]. Consequently, they are often unaffordable and are maladapted to low resource settings.

Whereas rural health care providers are a documented source of grassroots technical innovation on a micro scale [ 3 ] the private industry world-wide has valuable expertise in the development of medical devices for mass use [ 2 ]. However, the industry has traditionally perceived that developing-world markets are too small to justify the development of new products [ 2 , 4 ]. Thus, over the past decade, a number of push and pull incentives have been proposed by international public health organizations, non-governmental organizations (NGOs) and donors in order to incentivize the western industry to undertake research and development (R&D) addressing the specific needs of the developing world [ 4 , 5 ], although market access challenges of this industry in such markets have been well-documented [ 6 ]. More recent is health technology innovation, largely by young companies located in developing countries, where the companies perceive local markets as the main focus of their R&D strategy [ 7 , 8 ].

Important to health technology innovation is Health Technology Assessment (HTA), defined as the “systematic evaluation of the properties and effects of a health technology, addressing the direct and intended effects of this technology, as well as its indirect and unintended consequences, and aimed mainly at informing decision making regarding health technologies” ( http://htaglossary.net ). In industrialized countries, there is a growing interest in interactions among bodies concerned with HTA, coverage (institutional purchasing or reimbursement), and regulation with whom the industry needs to engage in order to develop novel products that can reach patients [ 9 ]. Improving such interactions is believed “to speed patient access to valuable products” and “to remove unnecessary barriers to successful development and appropriate market access for innovative products” [ 9 ].

In contrast, India doesn’t have a formalized national HTA process and the public financing of new technologies is very limited [ 10 ]. Whereas 60-80% of health care is delivered in the private sector, only 3-5% of the population has health insurance [ 11 ] so coverage decisions by insurers have negligible impact on the market uptake. Further, medical practitioners in the private sector are not obliged to follow any official evidence-based guidelines, and continuous medical education is not mandatory [ 12 – 14 ]. Finally, the regulation of medical devices is minimal: in the case of in-vitro tests, only those for HIV, hepatitis B and C and blood typing are considered 'critical’ by the Indian regulator and only these tests must be clinically validated before receiving a license. In this context, our study aimed to provide qualitative insights into the frugal innovation experience of companies that function in an environment that doesn’t have a tradition of indigenous novel bio-medical product development.

Here we present case studies of six private companies in Bangalore, India, that have developed and launched (four cases) or are expecting to soon launch (two cases) devices for the Indian market. These firms belong to a new wave of intellectual property (IP)-based product ventures in the country. We study (i) the evolution of the firms and their approaches to product development; (ii) their funding and human resource challenges; (iii) their access to global science and technology (S&T); (iv) their use of global regulatory requirements, and finally (v) the market challenges that must be overcome in order to access patients with their products. We believe that insights from this study will be of interest to many young companies, regulators and policy makers in the world.

We adopted a qualitative case study research methodology that has been used by others to study medical innovation in developing countries [ 8 , 15 – 17 ]. The innovative medical device industry in India is only emerging today and a quantitative study would not be feasible with such a small sample size. Further, as explained below, the firms have gone through very different paths since their inception and the case study methodology is better suited to capture this heterogeneity. The study protocol was approved by the Ethics Committee of IBAB. Written informed consent was obtained from participants by asking them to positively reply to an interview invitation e-mail. Initially more than 40 private and government doctors, diagnostic labs, manufacturers and distributors of diagnostic tests, NGOs and academics were interviewed about the diagnostics’ business in India. The interviews concerned local innovation versus imported products, delivery of devices to patients in public and government sectors, regulatory issues and doctors’ prescription behaviour. Informants were chosen by purposeful sampling and were chiefly located in metropolitan cities although their experience extended to rural areas as well. Results of these interviews are not presented here, but served to select the six companies located in Bangalore that were the basis for this study. Additionally, the following sources were used: the BioSpectrum India Life Sciences Resource Guide 2010 which is one of the most comprehensive repositories of information on the Indian life science industry ( http://www.newindigo.eu/biotech/main/index.htm ) and a published review of the Indian biotech industry [ 18 ]. Since none of the firms had achieved significant sales at the time of our research, financial measures such as profit, volumes or return on investment could not be used as criteria for selection. Nor were details of debt or equity available for the (largely) privately held companies. We selected medical device firms located in Bangalore, arguably the most innovative biomedical hub in India, that were developing innovative, IP-based products for the Indian market, and low-resource settings in particular. Finally, in the one situation where two companies with similar profiles were identified (that is, inception or origin, type of product and development path) the company that was further in the product development process was chosen. The company-specific interviews sought to understand the inception of the firm and the origin of the key personnel; the path of product development and target product profiles; sources of funding; issues related to clinical validation; regulatory approval and market access in private and government settings. Interviews were not recorded but detailed notes were made during and immediately after each interview. The analysis presented here is based on multiple interviews with the founders of five of the companies. In the case of GE Healthcare India (GEH) the informant was the senior product manager who led the development of MAC400 and MACi. Consequently, the perspective of his own R&D centre may not fully reflect the history of General Electric (GE) in India. In each case there was one interview at the company, followed by a few more conversations in person, by phone or by e-mail. Further information was obtained from company material and other published interviews of the founders. After all the interviews, the write up on each of the six companies was verified by the concerned firm. However the final manuscript was not submitted to them for their verification. All interviews were semi-structured and were conducted between March and December 2011, inclusive.

The companies and their products

The firms profiled are XCyton Diagnostics (XCyton), Bigtec Labs (Bigtec), GEH, ReaMetrix India (ReaMetrix), Embrace Global (Embrace) and Achira Labs (Achira). The companies were founded from 2 to 18 years ago (Table  1 ). Interestingly the founders of these six firms came from six of the nine categories of biotech founders in India, identified previously [ 18 ]. The earlier study had pointed out a low rate of company formation by local academics, and that is reflected here, where none is a scientist from local academia (Additional file 1 ). In terms of the companies’ evolution GEH started as a manufacturing support unit of GE Healthcare Worldwide's Indian manufacturing facility and then evolved into an R&D centre. The remaining ventures started as R&D firms and this has remained unchanged (Additional file 2 ). Most of the firms were able to take their products from concept to clinical validation in two to three years. The exception was Bigtec where the founders operated in a field that was unfamiliar to them, and where – when the product launches later this year – it will have taken 12 years from the firm’s founding.

Each firm wanted its products to be appropriate for use in low-resource settings which constitute the bulk of the Indian market both in volume and in overall value. Thus, each company undertook an independent assessment of the needs of health-care providers in such settings. It went on to construct product profiles according to its own market- and consumer-research without guidance from national health-care payers or regulators. Low-cost was therefore a common criterion, although other specifications varied with the company (Additional file 3 ). Each firm’s route to its product(s) is outlined below.

XCyton develops diagnostic kits for infectious diseases. It has relied on (i) an invention sourced from the local R&D centre of a multinational company (MNC) (one case), or (ii) science sourced from or products developed in collaboration with Indian public or private research institutions (11 cases). These scientific collaborations were enabled by the personal contacts and informal links of the founder to local scientists. They were unofficial collaborations with low administrative burden and great flexibility in negotiation. Initially, XCyton developed ELISA-based kits (CheX) which require a generic reader but are relatively easy to perform even by untrained manpower. Later, the company developed polymerase chain reaction (PCR)-based kits (XCyto Screen) which call for skilled staff and dedicated laboratory facilities. This shift from rapid kits to high-resource technology was partially motivated by fading confidence in the public health-care market.

ReaMetrix started out as a contract research organization (CRO) offering services to Western clients. This led to a gradual build up of its capabilities and capacity. Subsequently the firm changed track and developed a proprietary dried reagent tailored to the needs of the National AIDS Control Organization (NACO) program which covers approximately 50% of the patients on anti-retroviral treatment in India. This reagent is used for a flow-cytometer-based test which monitors the patient’s absolute CD4+ and CD8+ T-cell counts and can replace a more expensive product supplied to NACO by an MNC. Also, it (i) removes the necessity of both cold-chain distribution (storage and transport) and on-bench refrigeration and (ii) reduces the possibility of procedural errors by supplying the pre-weighed reagent in ready-to-use disposable tubes. The company went on to develop a cheaper, simpler and more robust fluorescence reader that can replace the flow-cytometer that was supplied to NACO by the MNC. The company estimates that the currently used instrument costs $20,000–90,000 and it is willing to offer its reader at $15,000–20,000. In resource-limited settings it would offer a reagent rental scheme wherein the cost of ownership of the machine is zero. However, disappointed with the government market, the company is considering re-inventing itself yet again to build advanced R&D instruments for Western markets.

Initially Bigtec worked on a recombinant insulin for the Indian market. Subsequently it shifted to an innovative PCR-based microfluidics platform for the detection of infectious diseases specific to India. Notably, the founders were not microfluidics’ specialists. They were nevertheless attracted to this technology because it offers the automation and short sample processing times necessary in point-of-care settings. The diagnostic device allows sample preparation and mixing, bio-chemical reactions and sample screening and detection to be performed on a single chip. The diagnosis takes 45 minutes rather than several hours, and can be performed in harsh environmental conditions by an untrained person. The technology has been clinically validated for several diseases. Bigtec is planning to price the device below the cost of a real-time PCR machine. The cost of running a test would be similar to that with a currently available in-vitro diagnostic (IVD) kit for the concerned infection.

GEH started as a low cost, off-shored manufacturing unit of the mother MNC. Subsequently, it developed the MAC400 electrocardiogram (ECG) device for emerging markets by removing some features from an existing GE model. It was the first product released for the Brazil, Russia, India and China (BRIC) markets and was priced at $800, compared with GE’s other hospital-class ECG units that had a price tag between $2,000 and $10,000. However, the development of the next ECG device, MACi, was specific to the Indian market. The needs of rural health-care practitioners were surveyed by engineers from several Indian states. This was felt to be a necessity in a country with a multitude of local languages, a range of geographies and wide disparities in income-levels. It featured a fast-charging, long-life battery and was robust and portable. Also, the company realized that the poorly-regulated local market was dominated by very low-cost ECG machines, which was rather unique among BRIC countries. MACi was therefore priced at $500. It was released on the market just one year after product conceptualization. The emergence of GEH as an innovative product development centre capable of the entire design, development and manufacturing of a product was enabled by two key factors: extensive supervision and deliberate technology transfer from GE R&D units located in Germany and the US, as well as the initiative and corporate advocacy of a team at GEH for the development of a product tailored to the Indian market.

Embrace was set up to develop and commercialize a portable and safe warmer for low-birth infants. Although initially based in the US, it relocated to India, where the core R&D team made field trips to rural and urban settings in order to consult with potential end-users. One version of the warmer has been developed for use in hospitals and clinics. In the former setting it facilitates the inter-ward transfers of infants which might take up to 40 minutes. It is available for less than $300 compared to $580–$1900 for currently used radiant warmers. Another version is being developed for use at home and in rural settings. In all settings, Embrace’s warmers would replace potentially dangerous electric radiators which can accidentally catch fire.

Achira was set-up to capitalize on the founder’s academic expertise in microfluidics. Although it started out intending to provide such services to large global pharmaceutical companies, it soon shifted focus to developing a lab-on-chip platform for low-resource health-care providers in India. Achira is developing two immunoassay-based platforms: (i) microfluidic chips with a dedicated fluorescence reader for quantitative assays and (ii) device-free silk fibre-based chips for qualitative assays, which can be read by the naked eye. The former technology generates results in less than 30 minutes and can be used with minimal technical training. It has been internally validated by the company and external validation is planned. The latter technology is currently being optimized. It is superior to the currently available lateral-flow technology because multiple types of tests can be performed on a single chip. Its large-scale manufacture requires only low-cost physical infrastructure and therefore it will be sold at a lower price than the first platform.

In order to protect their inventions, all the firms filed patents, in India and in other countries. There was a general tendency to first file the applications in India and then in the US and Europe. However, we formed the impression that the young companies did not have an established IP policy.

Human resources

The Indian medical industry has traditionally been based on reverse-engineering, and therefore many skills required for the development of entirely novel products are rare in the country today [ 19 ]. Consequently the companies faced a few challenges related to the recruitment and retention of appropriately skilled personnel. (i) Indians returning from Western nations, with postgraduate academic degrees or industry experience, played an important role in most of the firms (Additional file 1 ). The process has been accelerated by both the recent economic growth in urban India and the economic stagnation of Western economies. (ii) All the firms have found that neither candidates with experience in the local pharmaceutical industry nor graduates of local academic institutions have the right skill sets to work on the design and marketing of innovative products. Whereas senior scientific staff in the companies are able to train new employees in technical skills, finding experienced candidates for market access activities has been a key challenge. (iii) XCyton and Achira, which employ Indian biologists with postgraduate experience, have found that there are cultural issues related to retaining their staff for long periods. As elsewhere, many biologists in India are women, and there is high attrition due to the relocation of those who follow their spouses to other cities. This churn has serious costs for young firms, in terms of both time and money.

Funding of the companies

The studied companies managed to engage with both local and international investors to fund their R&D programs, without having to forgo majority equity. It turns out that half of the firms were primarily funded from Indian sources and the other half from foreign ones, as detailed below (more details in Additional file 4 ).

Primarily Indian sources

Among the indigenous start-ups, XCyton and Bigtec benefitted from soft loans and small grants for young R&D firms from the Government of India, and this funding was vital. Both companies have had difficulty finding investors who would be willing to fund marketing and distribution activities without taking a majority share. They perceive such offers as unfair since their products have already been clinically validated and therefore the investment would carry relatively low risk. However, XCyton has very recently obtained an equity investment from a US-based entity which will be used mainly for marketing its XCyto Screen services and also to establish new laboratories across the country. Interestingly, this forced the company to discontinue the two approved CheX tests (for HIV and hepatitis C). This was necessary to avoid being classified as a pharmaceutical company under Indian law and it enabled XCyton to finalize the foreign investment deal without government pre-approval.

Primarily Western sources

In contrast to the cases above, ReaMetrix was almost entirely dependent on the private money of the founder who has been a serial entrepreneur in the US, and on international private investors. Although GEH is a division of a global corporation, funds for the development of an ECG for the local market were not granted automatically. After the India-based team of engineers took the initiative, their ideas received financial support first from global headquarters and later from a locally created budget. Finally, Embrace was established as a social enterprise and was funded by US-based donors. The founders are now planning to split the enterprise into a non-profit and a for-profit entity, the latter in order to secure the substantial international investment necessary to enable large-scale manufacturing and global marketing.

Overall, the firms’ major struggle was in raising substantial funds for marketing as well as scaling-up manufacture. Apart from Bigtec which formed a product marketing joint-venture with a major Indian diagnostics manufacturer, the companies needed to rely on foreign investment to finance such activities. Some of the firms fear that an investment by an MNC would result in a loss of control of the pricing strategy, and force them to price their products higher than they would wish even in low-resource settings.

Globalization of science and technology

Overall, the companies value being located in India. It has allowed them to organize frequent field surveys, construct meaningful product specifications and experiment with market access strategies, all with respect to low resource settings. Notably, however, each firm's ability to develop such appropriate technologies was enabled by the founders’ or other key persons’ experience in Western academia or industry (Table  2 and Additional file 1 ). Contact with global S&T occurred in the local divisions of MNCs (XCyton and GEH) or through returning Indians (the other firms). Also, for some of the firms, pre-existing international links were instrumental in accessing Western clients and/or funding sources, which were essential in the early days (Table  2 ). Since the availability of manufacturers and suppliers of advanced services and components in India is limited, this posed a challenge to several of the companies. Being a division of an MNC, GEH has an international network of accredited providers which facilitated sourcing of specific components. However other companies had to establish partnerships with industry located in Europe or the US. These were often initiated during global charity or industry meetings or through international academic collaborations (Additional file 5 ). Thus, medical technology innovation in a developing country can require outsourcing to the West due to the lack of local facilities or expertise.

Experience with international regulatory authorities

The companies’ international reach concerns not only S&T but also regulatory approval for their products. This is mainly because the regulation of medical devices in India is rudimentary. Further, the regulatory body is not accustomed to licensing innovative products that have not been approved in a developed country. Some firms were dissatisfied with the limited regulation in the country primarily for two reasons: (a) the lack of dialogue and guidance on what specifications a product should meet and (b) unfair competition from manufacturers offering sub-standard and cheaper versions of their innovative products.

In the absence of local regulation, the companies pursued WHO pre-qualification, US Food and Drug Administration (FDA) approval or the CE mark (Additional file 4 ). It was considered necessary to engage with foreign regulatory agencies not only for their guidance and to distinguish the companies’ innovative products from substandard ones, but also for accessing global markets, including those of low-income countries. Surprisingly, as exemplified by the struggle of XCyton, even WHO pre-qualification involves mobilizing significant resources. Thus, whereas the company’s HIV CheX test was compliant with WHO guidelines, pre-qualification came only after a two-year effort to attract the attention of the relevant officer who was based in Geneva. Notably, this contract gave XCyton global visibility. Subsequently, international organizations have helped the firm obtain accreditation abroad for other tests.

The firms have also pursued international certifications due to the high uncertainty related to the Indian public market, that is discussed further below. The companies that have tried to sell to the Indian government have failed to do so. Therefore, the companies have accessed, or have considered accessing, the local market via funding from foreign donor organizations. For this, international accreditation of their products would be required.

Accessing the market

Health-care providers in India range from high-end private hospitals manned by highly qualified personnel and equipped with the latest technologies, to public and private rural health-care centres lacking trained staff and with serious shortcomings in basic facilities such as the availability of uninterrupted power and water. This has large implications for the product planning process since there is significant uncertainty regarding the kind of end users and their sample throughput needs, as well as the target price range. The companies’ perception is that whereas high-end settings require high throughput capacity of an instrument and national or international accreditation, other settings primarily require (i) low capital investment and maintenance costs, (ii) low costs to the patient, (iii) resistance to adverse operating conditions and (iv) the equipment should be explicitly designed to facilitate task shifting to lower cadres of workers. Consequently, the companies have found that reaching such complex markets requires more time than product R&D. Notably, the experience of GEH in marketing to high-resource settings in India proved insufficient to access low-resource settings with the MACi. Thus, for the Indian market, the key obstacles to reaching the customer have been: (a) an underfunded and non-transparent government health-care market and (b) a highly fragmented and poorly regulated for-profit private market. In the case of diagnostics, soaring competition among diagnostic labs has increased the occurrence of referral fees that are paid to doctors on a per patient basis. It is also complex and costly to access African countries, even via the WHO purchasing process. XCyton and Embrace said that the largest funding rounds in their existence would be used in large part for marketing and distribution. These obstacles are discussed in Additional file 6 .

Five of the six companies discussed here took their products from concept to validation in two to three years. This compares well to the average product lifecycle of 18–24 months estimated by Eucomed, the medical technology industry body in Europe ( http://www.eucomed.org ). However, the availability of both funding and the human resources necessary to access the market with finished products has been one of the major impediments to the companies. Whereas advanced technological knowledge could be accessed via links to global academic and industry communities, the lack of local regulatory guidance posed a major challenge for product development. Although FDA, CE and WHO certifications are an alternative, the interviewed companies assert that the high cost of such procedures and/or distant location of these agencies are serious obstacles and result in delays. Whereas there is scarcity of literature on the innovative health care industry in India, some of these issues have been reported previously [ 17 , 20 ]. Further, the paucity of institutional health care payers, the fragmentation of private health-care providers and the lack of national consensus guidelines meant that the companies had to use their own resources to educate the doctors and laboratories about their technologies. Notably, the for-profit nature of the private sector demands that when pricing their products, firms must consider both the affordability for the patient and the provider’s desire to generate profits from the provision of a technology [ 12 , 21 – 23 ]. This market complexity implies that the commercial success and survival of such companies will depend on their ability to develop ground-breaking strategies in the post-R&D phase also.

We believe that the future of India’s innovative biomedical industry will depend on the upgradation of several national policies. Whereas this study was not designed to inform such policies, and tools such as stakeholder analysis are better suited for this purpose than the case study method adopted here, we would like to make three recommendations for the development of an innovative medical device sector in India: First, the national regulatory bodies need to offer guidance to industry about product development as the FDA, European Medicines Agency and WHO do. Currently, the scientific capabilities of the relevant agencies are inadequate to do this. Second, government procurement of innovative devices needs to be increased. Also, the process to do so should be made more transparent through the incorporation of explicit evidence-based decision making. The UK’s National Institute for Health and Clinical Excellence and similar government agencies in many other European and some Asian countries, such as Japan, Singapore and Malaysia, appraise medical technologies and advise on their financing from public sources. Third, the private healthcare sector requires more regulation. This implies tackling the issue of referral fees and the production of national guidelines for diagnosis and treatment. In many countries that have nationalised health systems this is achieved through close collaboration between the HTA bodies, medical councils that control doctors’ practice and the national health funds or insurers that directly employ most health care professionals. However, it remains to be seen whether such centralized control can or should be achieved in a large and diverse country such as India, that has a health care sector that is highly fragmented and largely private.

Abbreviations

Achira labs

Bigtec labs

Brazil Russia, India and China

Contract research organization

Electrocardiogram device

Embrace global

General electric

GE Healthcare India

Health technology assessment

In-vitro diagnostic

Multinational company

National AIDS Control Organization

Non-governmental organization

Polymerase chain reaction

ReaMetrix India

Science and technology

XCyton Diagnostics

Intellectual property

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Acknowledgements

We are grateful to all the interviewees from the studied companies who generously contributed their time. We are also very grateful to the Institut Merieux (IM), Lyon, which funded this study as part of support to several of GS’s projects. SJ is supported financially by France Volontaires, Ivry-sur-Seine.

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Competing interests.

GS’s research is funded by Institut Merieux (IM) which has financial interests in the medical technology industry. However IM did not play any role in designing this study, or in any other aspect related to it other than general funding, as indicated below.

Authors’ contributions

GS proposed the study. SJ performed and analysed the interviews. SJ and GS wrote the manuscript. Both authors read and approved the final manuscript.

Electronic supplementary material

Additional file 1: detailed profiles and origins of the founders and key people in the studied companies.(doc 38 kb), additional file 2: key events in the evolution of each company and sources of innovation.(doc 34 kb), 12913_2012_2626_moesm3_esm.doc.

Additional file 3: Key criteria considered by the companies when constructing product profiles for their devices and other issues of product development.(DOC 36 KB)

Additional file 4: Sources of funding for the studied companies.(DOC 33 KB)

12913_2012_2626_moesm5_esm.doc.

Additional file 5: Details of the six companies’ pursuit of global (i) science and technology and (ii) regulatory requirements.(DOC 34 KB)

12913_2012_2626_MOESM6_ESM.doc

Additional file 6: Challenges faced by each company in accessing the Government and private markets in India or other developing countries.(DOC 36 KB)

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Jarosławski, S., Saberwal, G. Case studies of innovative medical device companies from India: barriers and enablers to development. BMC Health Serv Res 13 , 199 (2013). https://doi.org/10.1186/1472-6963-13-199

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Received : 08 August 2012

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DOI : https://doi.org/10.1186/1472-6963-13-199

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National Academy of Medicine

Telehealth and Mobile Health: Case Study for Understanding and Anticipating Emerging Science and Technology

case study medical technology

Introduction

This case study was developed as one of a set of three studies, focusing on somewhat mature but rapidly evolving technologies. These case studies are intended to draw out lessons for the development of a cross-sectoral governance framework for emerging technologies in health and medicine. The focus of the case studies is the governance ecosystem in the United States, though where appropriate, the international landscape is included to provide context. Each of these case studies:

  • describes how governance of the technology has developed within and across sectors and how it has succeeded, created challenges, or fallen down;
  • outlines ethical, legal, and social issues that arise within and across sectors;
  • considers a multitude of factors (market incentives, intellectual property, etc.) that shape the evolution of emerging technologies; and
  • identifies key stakeholders.

Each case study begins with two short vignettes designed to highlight and make concrete a subset of the ethical issues raised by the case (see Box 1 and Box 2 ). These vignettes are not intended to be comprehensive but rather to provide a sense of the kinds of ethical issues being raised today by the technology in question.

case study medical technology

The cases are structured by a set of guiding questions, outlined subsequently. These questions are followed by the historical context for the case to allow for clearer understanding of the trajectory and impact of the technology over time, and the current status (status quo) of the technology. The bulk of the case consists of a cross-sectoral analysis organized according to the following sectors: academia, health care/nonprofit, government, private sector, and volunteer/consumer. Of note, no system of dividing up the world will be perfect—there will inevitably be overlap and imperfect fits. For example, “government” could be broken into many categories, including international, national, tribal, sovereign, regional, state, city, civilian, or military. The sectoral analysis is further organized into the following domains: science and technology, governance and enforcement, affordability and reimbursement, private companies, and social and ethical considerations. Following the cross-sectoral analysis is a broad, nonsectoral list of additional questions regarding the ethical and societal implications raised by the technology.

The next section of the case is designed to broaden the lens beyond the history and current status of the technology at the center of the case. The “Beyond” section highlights additional technologies in the broad area the focal technology occupies (e.g., neurotechnology), as well as facilitating technologies that can expand the capacity or reach of the focal technology. The “Visioning” section is designed to stretch the imagination to envision the future development of the technology (and society), highlighting potential hopes and fears for one possible evolutionary trajectory that a governance framework should take into account.

Finally, lessons learned from the case are identified—including both the core case and the visioning exercise. These lessons will be used, along with the cases themselves, to help inform the development of a cross-sectoral governance framework, intended to be shaped and guided by a set of overarching principles. This governance framework will be created by a committee of the National Academies of Sciences, Engineering, and Medicine (https://www.nationalacademies.org/our-work/creating-a-framework-for-emerging-science-technology-and-innovation-in-health-and-medicine).

Case Study: Telehealth

As far back as the Civil War, the United States has used electronic means (in this early example, telegraphs) to communicate patient health information. After a long, slow ramp-up, there has been steady evolution and growth in electronic health data and communication since 1990, pulled by advances in technology and pushed by changes in regulation.

Prior to the COVID-19 pandemic, which began in March 2020, three broad trends were under way in the evolution of telehealth: first, a shift in application from efforts to expand health care access that motivated early use to the use of telehealth to control costs; second, the expansion of telehealth use from the context of acute care to the management of chronic conditions; and third, a transition of the site of care from health care institutions to patients’ homes and mobile devices (Dorsey and Topol, 2016). The recent exponential increase in mobile health applications and physical distancing requirements that accompanied the pandemic have dramatically accelerated the evolution and adoption of telehealth (Olla and Shimskey, 2014).

It is important to note that “telehealth” and “mobile health (mHealth)” do not have consensus definitions, nor do many other terms used in this space, such as “electronic health (eHealth),” “telemedicine,” and “digital health” (HealthIT.gov, 2019; Doarn et al., 2014; WHO, 2010). From a regulatory perspective, definitions are important because countries and states must describe what they do and do not regulate and how (Hashiguchi, 2020). In the United States, telehealth is generally the umbrella term covering telemedicine (defined as provider-based medical care at a distance); telemedicine within medical specialties such as telepsychiatry, telestroke, and teledermatology; and mHealth (initially used to describe care provision through text messaging, but now includes the use of wearable and ambient sensors, mobile apps, social media, and location-tracking technology in service of health and wellness) (APAa, 2020; Sim, 2019; CMS, 2011).

One widely used definition of telemedicine—the component of telehealth with the longest history—is from the World Health Organization (WHO), which defines it as, “The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interest of advancing the health of individuals and their communities” (WHO, 2010).

In Norway, an early adopter and regulator of telemedicine, “telemedicine” is defined by law as “the use of videoconferencing to perform an outpatient consultation, examination, or treatment at a distance” (Zanaboni et al., 2014). In South Africa, by contrast, telemedicine is defined not by statute but by the Health Professions Council of South Africa as “using electronic communications, information technology or other electronic means between a health care practitioner in one location and a health care practitioner in another location for the purpose of facilitating, improving and enhancing clinical, educational and scientific health care and research” (HPCSA, 2020).

Telehealth can include everything from medical websites (e.g., the Mayo Clinic, WebMD) to remotely controlled surgical robots. Telehealth can also be categorized into groups of technologies, including interactive telemedicine (including video visits and electronic consults between providers), telemonitoring, store-and-forward technology (the collection and use of non-urgent medical information), and mHealth.

Early applications of telehealth were designed to expand access, and in fact, telehealth has been critical (if not entirely successful) in this regard. There are, of course, long-standing and persistent concerns about the number and geographic distribution of health care providers, and telehealth has improved access to those in remote and historically underserved populations in states such as Alaska and Texas, as well as for those in the military (e.g., those at sea or in a combat zone), prisons, and astronauts (NRHA, n.d.). Telehealth has also expanded access to language interpreters and specialists for patients with rare disease.

Telehealth, as it is traditionally construed, offers significant benefits, but it also raises a number of concerns. These concerns pertain to the use of telehealth in and of itself and the ways in which availability has been exponentially and almost instantaneously expanded in response to the COVID-19 pandemic and in recent years by mHealth. One broad issue, at least in the United States prior to the COVID-19 pandemic, is the shift mentioned previously from a focus on the use of telehealth to expand access to health care to the use of this technology to cut health care costs (Dorsey and Topol, 2016). In addition, and despite the dramatic expansion in telehealth, many of those most in need remain without access to high-quality health care (Park et al., 2018). On the individual level, telehealth raises concerns not only about privacy, both due to the site of care and the transmission, storage, and sharing of data, but also about both concrete and intangible losses related to physical distancing from the care relationship and ‘the healing touch’ (Bauer, 2001).

Guiding Questions

(derived from global neuroethics summit delegates, 2018; mathews, 2017).

The following guiding questions were used to frame and develop this case study.

  • Historical context: What are the key scientific antecedents and ethics touchstones?
  • Status quo: What are the key questions, research areas, and products/applications today?
  • Cross-sectoral footprint: Which individuals, groups, and institutions have an interest or role in emerging biomedical technology?
  • Ethical and societal implications: What is morally at stake? What are the sources of ethical controversy? Does this technology or application raise different and unique equity concerns?

Additional guiding questions to consider include the following:

  • Key assumptions around technology: What are the key assumptions of both the scientists around the technology and the other stakeholders that may impede communication and understanding or illuminate attitudes?
  • International context and relevant international comparisons: How are the technology and associated ethics and governance landscape evolving internationally?
  • Legal and regulatory landscape: What are the laws and policies that currently apply, and what are the holes or challenges in current oversight?
  • Social goals of the research: What are the goals that are oriented toward improving the human condition? Are there other goals?

Historical Context

What are the key scientific antecedents and ethics touchstones.

Despite its association for most people with the last decade or even just with the COVID-19 pandemic, telehealth was first employed in the United States more than 100 years ago—one of the first health-related telephone calls was described in 1874 (Nesbitt and Katz-Bell, 2018). In 1905, the first “telecardiogram” was recorded and sent by telephone wire from a laboratory to a hospital (IOM, 2012). By the 1920s, Norwegian providers began giving medical advice to clinics on ships over radio, a use that quickly spread to other parts of the world (Ryu, 2010).

Over time, technology and applications expanded to include transmission of images and video. Teleradiology has been used for more than 60 years in the United States, with some of the first radiologic images transmitted by telephone between West Chester, Pennsylvania and Philadelphia, Pennsylvania, in 1948 (Gershon-Cohen and Cooley, 1950). Similar use in Canada soon followed.

The first use of interactive video in health care communications in the United States likely occurred at the University of Nebraska in 1959, through the transmission of neurological exams (Wittson and Benschoter, 1972). In an early and famous use of telemedicine, Norfolk State Hospital employees provided psychiatric consultations for the Nebraska Psychiatric Institute in the 1950s and 1960s (IOM, 1996). Wireless transfers of electrocardiogram and X-rays became prominent around this time as well (IOM, 1996).

In collaboration with the state of Arizona, the National Aeronautics and Space Administration (NASA) advanced satellite-based telemedicine in order to provide future care to astronauts, while also benefiting the Papago Indians in Arizona through a demonstration project called the STARPAHC (Space Technology Applied to Rural Papago Advanced Health Care) project (Freiburger et al., 2007). During the 1970s, the use of this technology spread to other parts of the United States, serving remote and historically underserved communities, such as those in Alaska (Nesbitt and Katz-Bell, 2018). However, without private-sector investment, such projects were not sustainable, leaving the populations they were designed help without the capacity to maintain the expanded access (Greene, 2020).

Following slow growth in the 1980s, the 1990s saw a great expansion of telehealth use and services through the development of statewide telemedicine projects, passage of state and federal legislation making telemedicine services reimbursable, and increasing affordability of telemedicine (Nesbitt and Katz-Bell, 2018). The hub-and-spoke model emerged in which multiple distant care sites were connected to a larger specialty health center. These programs were often funded through legislative appropriations or grants and focused on increasing outpatient access to specialty care (particularly for patients in remote or historically underserved areas) and provision of continuing provider education. Many health systems, which have traditionally operated as competitors, formed telehealth alliances, such as the New Mexico American Telemedicine Association, in order to decrease barriers to health care (Nesbitt and Katz-Bell, 2018).

Research on the efficacy of telehealth also dramatically increased in the 1990s. Publications from the Veterans Health Administration (VHA) and Kaiser Permanente added to the telehealth evidence base and suggested that home telehealth may benefit some patients (Darkins, 2014; Johnston et al., 2000). Telehealth also became more common in correctional facilities due to the costs and significant risks in transporting patients to physically see health care providers (Nesbitt and Katz-Bell, 2018).

Throughout the early 2000s, telemedicine platforms multiplied across states (every state had a platform by 2010) and around the world (Nesbitt and Katz-Bell, 2018). The Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act, enacted in 2001, lowered barriers to telehealth in a number of ways, including requiring payment parity (equivalent payment for in-person and telemedicine visits) by Medicare, requiring Medicare to pay a $24 facility fee payment to the originating site for each telehealth visit, and expanding the range of telehealth services covered under Medicare (Gilman and Stensland, 2013; 106th Congress, 1999). In addition, Teladoc Health, now the world’s largest telemedicine company, was launched in 2002 (Teladoc Health, 2022).

Inpatient and emergency care telehealth services then started to become more common. teleICU care increased and began to incorporate interactive video conferencing and smart alarms in intensive care units (ICUs) (Lilly et al., 2011). The Department of Veterans Affairs (VA) led the way in adapting telehealth to care for patients with chronic health conditions (Nesbitt and Katz-Bell, 2018).

In 2008, the Medicare Improvements for Patients and Providers Act further expanded both covered services and eligible providers, including community mental health centers (Gilman and Stensland, 2013). As internet speed and affordability improved, the Federal Communications Commission (FCC) provided grants to expand broadband to rural areas, further increasing the number of Americans who could access telehealth. In addition, the American Recovery and Reinvestment Act of 2009 helped expand telehealth services, with a focus on disaster preparedness (Nesbitt and Katz-Bell, 2018). The Office for the Advancement of Telehealth, within Health Resources and Services Administration (HRSA), part of the Department of Health and Human Services (HHS), helped start state clinical telehealth networks and funded telehealth research (Nesbitt and Katz-Bell, 2018).

By 2010, 11 states (California, Colorado, Georgia, Hawaii, Kentucky, Louisiana, Maine, New Hampshire, Oklahoma, Oregon, and Texas) had mandated that insurance payers cover telemedicine services (although each state’s rules varied) (Nesbitt and Katz-Bell, 2018). In addition, 36 states covered telehealth services under Medicaid (CCHP, 2018). In 2011, CMS approved proxy credentialing of providers for telehealth services, greatly decreasing barriers to access. Although some state Medicaid programs began to reimburse for more telehealth services, there was tremendous variation across states (Nesbitt and Katz-Bell, 2018). In 2016, 48 states and Washington, DC, reimbursed for live video telemedicine services, and 19 reimbursed for remote patient monitoring (CCHP, 2021). However, despite significant improvements in access for many, telehealth has increasingly received more attention from venture capital than from the sort of government and nonprofit actors that might deliver on the original promise of telehealth for the expansion of health care access to low-income and rural populations (Greene, 2020).

By 2016, 46 percent of health care providers reported using multiple forms of telehealth technology in practice (HIMSS Analytics, 2016). At this time, the top seven diagnoses for Medicare beneficiaries receiving telehealth services were related to mental health (CMS, 2018). In 2020, 85.8 percent of Americans had access to the internet, suggesting that a greater proportion of people in the United States might be able to access telehealth services (Johnson, 2022). However, access to the internet is far from the only barrier to accessing telehealth, while it is a major barrier—others include language barriers between patients and providers, digital literacy, and access to equipment (more on this subsequently) (Park et al., 2018).

What are the key questions, research areas, and products or applications today?

Telehealth and telemedicine occupy a rapidly evolving evidence development and regulatory space. While the literature on telehealth effectiveness is limited, it is expanding rapidly. A 2019 Agency for Healthcare Research and Quality (AHRQ) evidence review included 106 studies of telehealth effectiveness (Seehusen and Azrak, 2019). While evidence was insufficient or low for many specialties, moderate strength of evidence was found for telehealth effectiveness in wound care, psychiatric care, and chronic disease management. Furthermore, patient satisfaction with telehealth services has been consistently found to be high (Orlando et al., 2019; Kruse et al., 2017).

International regulation of telemedicine varies widely. In contrast to other areas of complex regulation, there have been to date no generally applicable treaties governing telemedicine or attempts at legally harmonizing the practice across jurisdictions. This even includes an absence of general laws across countries that are otherwise bound together by supranational organizations like the European Union (EU) (Callens, 2010). Where specific regulations do exist governing telemedicine apart from traditional medicine, almost all countries broadly regulate telemedicine on a national or supranational level in contrast the United States’ federalist (i.e., subnational) approach. Exceptions to this general observation include countries with similarly robust federalist structures like Spain, Australia, Canada, and, to a lesser extent, Germany, which, like the United States, allows subnational jurisdictions to implement their own regulations governing telemedicine (Hashiguchi, 2020). Countries that have specific broad, national legislation implementing a permissive approach to telemedicine include the Netherlands, Finland, Iceland, and Norway (Hashiguchi, 2020). Hungary stands, to date, as a major exception among countries with explicit telemedicine policy, with national legislation restricting (rather than permitting) the practice of telemedicine beyond what would be afforded absent the law (Hashiguchi, 2020).

In the United States, telehealth options for Medicare Advantage patients expanded in January 2020 with the enactment of the 2018 Bipartisan Budget Act, which removed requirements with respect to the originating (patient) and distant (physician) sites, allowing patients to access telehealth services from home (Contreras et al., 2020). In response to the COVID-19 pandemic, the U.S. federal government has relaxed many telehealth regulations and increased telehealth funding. The number of telemedicine visits dramatically increased across the country during the pandemic (Mehrotra et al., 2020). The CMS 1135 waiver and the Coronavirus Preparedness and Response Supplemental Appropriations Act, enacted in March 2020, expanded telehealth benefits for Medicare Advantage patients to patients with standard Medicare by removing requirements that patients be physically located within a health care facility in order to participate in telemedicine (116th Congress, 2020; CMS, 2020). CMS also established equivalent reimbursement (parity) for video telemedicine visits and traditional in-person visits (CMS, 2020). Furthermore, the HHS Office for Civil Rights relaxed the enforcement of software-based violations of the Health Insurance Portability and Accountability Act (HIPAA), enabling flexibility in platforms through which telemedicine is delivered, as huge amounts of health care shifted to telemedicine in a matter of days following the onset of the COVID-19 pandemic (HHS, 2020).

Medicaid has always allowed states the flexibility to reimburse telemedicine visits in whatever way they deemed best, and although many states already required private health insurance and Medicaid plans to cover telehealth, many more expanded these policies in response to the COVID-19 pandemic (APAb, 2022). Some states also relaxed state-specific licensure requirements, allowing providers to conduct telehealth (and teletherapy) services more easily across state lines, although as the pandemic wanes in the United States, states have begun rolling back such measures (PSYPACT, n.d.; Richardson et al., 2022).

Relaxed requirements and reduced barriers to access do not necessarily mean uniform increased utilization, however. A 2018 study found that from 2013 to 2016, though overall telehealth use increased dramatically, this increased use was largely driven by higher-income populations and younger Medicare beneficiaries (Park et al., 2018). Telehealth was less likely to be used by Medicaid beneficiaries and low-income and rural populations, even in states with less restrictive state telehealth policies (Park et al., 2018).

mHealth is much newer than telehealth, and its evidence base is smaller, but it is rapidly growing, seeing $8.1 billion in investments in 2018, aided tremendously by the high-powered computers the vast majority of us carry on our persons, the smartphone, which is designed to track our motion and position in three-dimensional space (Day and Zweig, 2019). mHealth app and device developers have taken advantage of this capacity to turn smartphones into fall detectors, spirometers, heart-rate sensors, and much more, not only expanding diagnostic and treatment options but also generating new kinds of health data and evidence (Sim, 2019). The Apple Health app can combine data collected from the iPhone or Apple watch with a consumer/patient’s electronic health record. The lucrative segment of mHealth focused on concierge care for those with means does expand access to care, but not in the way originally envisioned in the 1970s (Greene, 2020).

Apps specific to COVID-19 have also proliferated in the mHealth space. A survey of iOS and Android apps available between April 27 and May 2, 2020, identified 114 COVID-related apps, 84 (74%) of which were categorized as either health and well-being/fitness or medicine apps. About half of all apps were developed by regional or national governments, and all but one was free (Collado-Borrell et al., 2020).

As alluded to previously, access to the full range of telehealth services is dependent on access to high-speed internet (“broadband”), although it is important to note that a great deal of telehealth still happens by phone. According to the 2018 American Communities Survey (ACS), 18 million U.S. households lacked access to broadband, 60 percent of which had household incomes below $35,000/year (Siefer and Callahan, 2020). Additionally, the substantial racial disparities present in access to broadband can exacerbate racial disparities in use of telehealth (Singh et al., 2020). Internationally, it has been suggested that a 10 percent increase in internet access yields 1–2 percent increase in GDP (DeLaTorre, 2022). Policies aiming to address the “digital divide” are often targeted at building internet infrastructure in rural areas, but many Americans who lack access to broadband actually live in urban regions and are simply unable to afford all but the slowest internet speeds—a fact that has been made clear by stories of children and parents doing their schooling and jobs from the parking lots of public libraries and fast food restaurants during the COVID-19 pandemic (Greene, 2020; Kang, 2020). More inclusive efforts to close the digital divide have emerged, particularly in response to the growing need for broadband in the era of COVID-19. The HEROES Act, a COVID-19 relief bill passed by the U.S. House of Representatives in May 2020, included significant funding to help low-income households pay for broadband and acquire internet-capable devices, as well as funding to expand broadband access to urban health care providers left out of previous efforts to reach rural providers, though it did not receive a vote in the Senate (116th Congress, 2020; Cochrane, 2020). Versions of many of these provisions were maintained in the $900 billion stimulus bill that was signed into law in December 2020 (Montague, 2020).

Currently, the regulation of telehealth in the United States is at a major inflection point. The COVID-19 pandemic has dramatically altered the way that health care is sought and provided, and it is unlikely that the practice of medicine will return to the pre-COVID-19 status quo after the pandemic recedes. The rapid expansion in use of, and reimbursement for, telehealth services in the face of a global pandemic has accelerated the shift from traditional in-person medicine to a normalization of telemedicine. Similarly, the use of (largely non-evidence-based) health and wellness apps, as well as apps that enable digital contact tracing, has expanded over the course of the pandemic. How these products will be used and regulated in a post-COVID-19 world remains to be seen (Figueroa and Aguilera, 2020; JHU, 2020; Lagasse, 2020).

Cross-Sectoral Footprint

The cross-sectoral analysis is structured according to sectors (academia, health care, private sector, government, and volunteer/consumer—see Figure 1 ) and domains (science and technology, governance and enforcement, end-user affordability and insurance reimbursement [affordability and reimbursement], private companies, and social and ethical considerations). The sectors described subsequently are intended to be sufficiently broad to encompass a number of individuals, groups, and institutions that have an interest or role in telehealth. Health care is the primary nonprofit actor of interest, and so in this structure, ‘health care’ has replaced ‘nonprofit’, though other nonprofit actors may have a role in this and other emerging technologies, and, of course, not all health care institutions are nonprofits.

case study medical technology

Today, many telehealth technologies are researched, developed, and promoted by a scientific-industrial complex largely driven by market-oriented goals. The development of various components of telehealth may be altered by differing IP regimes. This larger ecosystem is also embedded in a broad geopolitical context, in which the political and the economic are deeply intertwined, shaping national and regional investment and regulation. The political economy of emerging technologies involves and affects not only global markets and regulatory systems across different levels of government but also non-state actors and international governance bodies. Individuals and societies subsequently adopt emerging technologies, adjusting their own values, attitudes, and norms as necessary, even as these technologies begin to shape the environments where they are deployed or adopted. Furthermore, individual and collective interests may change as the “hype cycle” of an emerging technology evolves (Gartner, n.d.). Stakeholders in this process may include researchers, technologists, business firms and industry associations, government officials, civil society groups, worker safety groups, privacy advocates, and environmental protection groups, as well as economic and social justice-focused stakeholders (Marchant et al., 2014).

This intricate ecosystem of stakeholders and interests may be further complicated by the simultaneous introduction of other technologies and platforms with different constellations of ethical issues, modes of governance, and political economy contexts. In contrast to the development of therapeutics or, to a lesser extent, medical devices, the development of telehealth technologies and platforms has not appeared to be controlled by the availability of intellectual property (McGowan et al., 2012). Subsequently, this ecosystem is disaggregated and organized for ease of presentation. This section will address both telehealth and mHealth but will endeavor to address telehealth first and then mHealth in the subsections. It is important to keep in mind that there are entanglements and feedback loops between and among the different sectors, such that pulling on a single thread in one sector often affects multiple areas and actors across the broader ecosystem.

Cross-Sectoral Analysis

For the purposes of this case study, the primary actors within the academic sector interested are those engaging in cost-effectiveness, comparative effectiveness, health services, basic and translational device, and mHealth research; and scholars working in bioethics.

Science and technology: Research on telemedicine has been conducted for decades, primarily focusing on effectiveness and cost relative to traditional in-person care (Torre-Diez et al., 2015). While the literature on telehealth effectiveness is limited, it is expanding rapidly. A 2019 AHRQ evidence review included 106 studies of telehealth effectiveness (Seehusen and Azrak, 2019). While evidence was insufficient or low for many specialties, moderate strength of evidence was found for telehealth effectiveness in wound care, psychiatric care, and chronic disease management. Furthermore, patient satisfaction with telehealth services has been consistently found to be high (Orlando et al., 2019). The evidence base for the use of telehealth and wellness apps (mHealth) is small, and more research is needed, particularly on the effects these technologies may have on reducing or exacerbating existing health disparities.

Governance and enforcement: Within the research context, governance is primarily through institutional human subject research review boards and research ethics boards, research funding bodies, academic publication standards, and scientific and professional societies (i.e., self-regulation).

Affordability and reimbursement: N/A

Private companies: N/A

Social and ethical considerations: There has been some academic research on social factors related to telehealth adoption and use, as well as ethical issues associated with telehealth adoption. There are related, growing literatures on the privacy and other implications of persistent data collection, big data, digital phenotyping, and so forth, with direct relevance to mHealth.

Health Care

Given the focus of CESTI on health and medicine, for the purpose of this case study, the primary actors within the nonprofit sector are those involved in health care.

Science and technology: As noted previously, research on efficacy across specialties is ongoing but limited.

Governance and enforcement: Health care systems are the main hubs for telemedicine. Their use of these technologies is subject to HIPAA regulation, as well as the licensing requirements of the state in which they operate. Proposals related to licensing for practicing across state lines could potentially change the reach of health systems (e.g., a proposal that licensing requirements only apply for the location of the telemedicine provider would enable a provider in a health system located in only one state to reach patients across the country) (Lee et al., 2020).

Physicians are governed by their respective state licensing boards. In general—and with the exception of psychiatry—state licensing boards do not grant their physicians blanket permissions or prohibitions to practice telemedicine, requiring only (again, in general) that physicians provide their patients “competent care” (APAb, 2022).

Professional bodies have also developed position papers regarding telehealth, including in the context of the pandemic (AHA, 2020). In Europe, there are cross-sectoral committees that include academics, industry/technology representatives, and regulators; similarly cross-sectoral committees were established in the United States to address the COVID-19 pandemic (NIH, 2020). These committees could potentially serve as a model for coordination of cross-sectoral governance of emerging technologies.

Affordability and reimbursement: The United States’ multimodal payer system makes reimbursement and payment for medical services in the United States difficult to summarize. Federally organized public payers (e.g., Medicare, Medicaid, the VHA) are largely governed by federal law, while strictures on state-level public and private payers are governed by state law. Each payer—including administrative agencies—sets different rates and schedules for each service, including those pertaining to telemedicine. Beyond this, states may have additional laws in place governing which services must be covered by private insurers.

Parity in reimbursement between in-person and telemedicine-based services remains an issue, and laws in some states require insurers to reimburse telemedicine visits at the same rate as in-person visits. From a health system perspective, this might make telemedicine an attractive option, as it is often less expensive to provide relative to traditional face-to-face care, though state medical boards have often required an in-person consultation before allowing for telehealth services (Lee et al., 2020). Furthermore, the traditional reimbursement model does not incentivize physicians to use telemedicine because they get paid more for in-person services and procedures (Goldberg et al., 2022). There are also basic questions related to implementation of telemedicine more broadly: What are the clinical workflows for telehealth care? How can physicians/health systems leverage and utilize remote monitoring effectively? How does data flow into the health system? Should these data be integrated with the medical record, and if so, how? Who is responsible for understanding and analyzing a potentially near-real-time stream of patient data? What are the shared expectations and liability concerns around these new platforms?

Private companies: Health care institutions partner with private companies that provide many enabling technologies for telehealth, including telemedicine care delivery platforms, monitoring and management technologies, mHealth apps, and more. While some of these technologies may be protected by trade secrets (e.g., confidential algorithms), few are robustly protected by patents given the difficulties in patenting software applications (Price, 2015). Furthermore, there have been calls for more rigorous testing of many of these technologies for clinical effectiveness (Sim, 2019).

Social and ethical considerations: While health data in the United States is regulated by HIPAA, there is no blanket data privacy law (104th Congress, 1996). Data privacy, like medical consent, is largely an issue of contract and tort. Data privacy is arguably the principal international issue concerning telemedicine regulation. Most significantly, the European Union’s General Data Protection Regulation (GDPR) provides a robust set of rights to individuals’ “personal data,” that is, “any information relating to an identified or identifiable natural person” (European Parliament, 2016). This includes the right to forbid its collection; to demand a third party destroy it; and, if electronic, to download it where it resides. Health data, specifically, receives further protections under the GDPR (although there are public health exceptions). The GDPR’s reach is not only cabined within the European Union but extends to anywhere in the world where the processing of European citizens’ data occurs. Penalties for noncompliance can be stiff (European Parliament, 2016). While other countries invested in telemedicine—including Colombia, Costa Rica, and Peru—have data privacy laws, the GDPR seems unique in its global reach and effect on data transmission practices.

In most countries, patient consent for telemedicine tracks with each respective country’s model for other forms of health care delivery. For example, where delivery operates at the physician level, patients’ consent typically is obtained through their physicians. Notable exceptions include Japan and Greece, which require explicit consent from patients before physicians can conduct treatment through telemedicine (Hashiguchi, 2020).

Physicians, particularly in subspecialties conducive to telemedicine (e.g., dermatology and psychiatry) may have workforce concerns as restrictions on cross-jurisdictional medical practice are relaxed. Providers may resist lowering licensing barriers as this could allow for competition from other states’ telehealth services (IOM, 2012).

As mentioned previously, the digital divide has significant equity implications for telehealth access, in addition to other challenges, including language barriers between patients and providers, digital literacy, and access to necessary equipment (Park et al., 2018). There are special issues related to safety, efficacy, and privacy/data security when mHealth devices/toys are used in the treatment of children (Comscore, 2014).

Private Sector

For the purposes of this case study, the primary actors within the private sector are digital health platform providers, startups, and app developers.

Science and technology: Telehealth startups are currently targeting large, self-insured employers with strong incentives to keep costs low (Dorsey and Topol, 2016). mHealth apps have been developed for a wide array of purposes, including tracking fertility and exercise; diabetes management; medication adherence; treating depression, anxiety, and traumatic brain injury; and preventing suicide.

Governance and enforcement: Many companies in the telemedicine space offer services designed to help physicians do their jobs and so fall under the umbrella of “physician practice,” which is not regulated by the U.S. Food and Drug Administration (FDA). Telemedicine platforms used by health systems are subject to stronger scrutiny, but in the interest of expanding access to telemedicine during the COVID-19 pandemic, the HHS Office for Civil Rights has “waived penalties for HIPAA violations against health care providers that serve patients through everyday communications technologies” during the public health emergency (HHS, 2020). There are thousands of health- and wellness-focused apps available for smartphones, some of which make dubious or unproven claims about their effectiveness. In addition to a shallow evidence base about the effectiveness of many health and wellness apps, they also raise significant privacy concerns because they are not all governed by the same privacy laws (like HIPAA) that protect sensitive patient information in traditional care settings (Singer, 2019). While some companies may be required or choose to engage third-party compliance services to monitor their data security, this is not a legal requirement for all.

The FDA’s Digital Health Software Precertification (Pre-Cert) Program has piloted new ways of regulating software-based medical devices, but this regulatory innovation has faced pushback from the U.S. Congress, suggesting that such innovation will be challenging (FDA, 2021; Warren et al., 2018).

Affordability and reimbursement: As described in more detail subsequently, states can and have mandated that commercial insurance plans offer parity for telemedicine visits (Yang, 2016). Historically, concern about medical liability has been a persistent barrier to the broader adoption of telemedicine (WHO, 2010). The United States, which has a robust medical practice tort system, appears to assign liability in much the same way for errors in telemedicine as it does for traditional practice. There is frequently lack of clarity about who should pay for mHealth technology, in particular when prescribed by a physician. Many mHealth apps are free or low-cost to download, though the safety and efficacy of many of these apps are unclear, and there are significant associated data privacy concerns.

As noted previously, an explicit goal of telehealth has long been expanded access in rural and remote areas. There are a number of companies that seek to address barriers to health and health care beyond geographic barriers and are focused squarely on improving equity in health care, such as ConsejoSano (SameSky Health), Hazel Health, and CareMessage (CareMessage, n.d., Hazel, n.d.; SameSky Health, n.d.).

At the same time, another major driver of telehealth is lowering the cost of health care. Insurers are motivated by the low cost of telehealth compared to the high cost of in-person care and self-insured employers also highly motivated to reduce costs and maintain a healthy workforce.

Private companies: One assessment of digital health startups highlighted 150 companies that had collectively raised more than $20 billion, and which had among them established partnerships with the American Heart Association, Sanofi, Cigna, Mount Sinai Health System, Mercy Health, and Arizona Care Network, demonstrating tremendous interest and growth in this space (CBInsights, 2021). Apple has partnered with both Aetna and the government of Singapore to incentivize individuals to engage in health-promoting behaviors. Fitbit has a similar partnership with United Health (Aetna, n.d.; Elegant, 2020; Gurdus, 2017).

Social and ethical considerations: Significant concerns about privacy, transparency, and accountability with regard to the algorithms and data generation by commercial devices and apps. As noted previously, there have been calls for more rigorous testing of many of these technologies for clinical effectiveness (Sim, 2019). The is often a wide range of third parties involved in telehealth delivery, some of which will be outside the “covered entity” and be governed by different (or few) rules (Gerke et al., 2020). Equity concerns are raised by algorithms trained on the healthy, well-off, and White.

For the purposes of this case study, the primary actors within the government sector are both the federal government and the states, which play critical gatekeeping (or facilitating) roles in the development and evolution of telehealth.

Science and technology: As noted previously, NASA and the VA have been leaders in telehealth research and development. The federal government also partners with tribal governments to administer the Indian Health Service (IHS), which provides care to American Indian/Alaska Native (AI/AN) people across the country. Telemedicine is particularly important to the work of the IHS due to the rurality of many AI/AN communities, which has led to innovation in telehealth systems (Hays et al., 2014). The IHS also has a Telebehavioral Health Center of Excellence, which offers behavioral health care and mental health care through multiple telehealth modalities (IHS, n.d.).

Governance and enforcement: U.S. federal and state governments have significant interests in the governance of telehealth. Prime among these is their interest in requiring public and private insurers to provide reimbursement for telemedicine services. As a result of the COVID-19 pandemic, CMS has waived reimbursement requirements that patients be physically located within a health center when receiving telemedicine services, making it possible for millions to access care safely from their homes. Every state has different reimbursement requirements for their state Medicaid plan, and states also have the power to control reimbursement parity for commercial insurance, which has led to the development of essentially 50 different reimbursement policies across the country.

As noted, the VA has been a leader in telehealth adoption and implementation, as they retain significant control over telemedicine and telehealth offered within the VHA, including control over licensure requirements and copay amounts (CRS, 2019). Since 2012, the VA secretary has had the ability to waive copays for telemedicine provided to veterans in their homes, and VA-employed providers can practice telemedicine across state lines with any patients within the VHA (CRS, 2019).

Another key role for the government is the protection of protected health information (PHI)—personally identifiable information that relates to a medical condition, the provision of care, or payment—which is regulated via HIPAA (104th Congress, 1996). HIPAA establishes restrictions on the dissemination of PHI by “covered entities”—providers, plans, clearinghouses, or business—without the express consent of the patient.

HIPAA is of particular concern in telemedicine because PHI is necessarily generated in telemonitoring and store-and-forward technologies. In addition, the nature of telemedicine is such that users of telemonitoring and store-and-forward technologies are almost certainly “covered entities” under the statute, that is, providers, businesses, or health care plans. In addition, HIPAA demands extra precautions from covered entities for most telemedicine applications under the HIPAA Security Rule, a regulation promulgated by HHS that concerns electronic PHI (CFR, 2011). Prior to the COVID-19 pandemic, the HIPAA Security Rule limited the types of platforms that could be used for the transmission of electronic PHI. In March 2020, the HHS Office for Civil Rights issued a Notification of Enforcement Discretion indicating that providers who engage in telemedicine using non-public-facing communication technologies in good faith will not be subject to penalties for noncompliance with HIPAA rules (HHS, 2021).

With respect to medical devices used in telemedicine, these are typically regulated at the federal level by the FDA (94th Congress, 1976). For example, the Da Vinci Xi Surgical System, a robotic surgical assistant and a form of interactive telemedicine, is regulated by the FDA as a Class II device (Stevenson, 2017).

Telemedicine encompasses devices in all three risk classes, from a WiFi-enabled digital pulse oximeter (Class I) to remotely controlled continuous glucose monitoring systems (Class III). In some instances, FDA considers software to constitute a medical device (FDA, 2017).

Affordability and reimbursement: See the previous discussion of reimbursement. Various national efforts to expand internet access have been key to the expansion of telehealth access, and will continue to be critical moving forward, as advanced technologies demand higher bandwidth.

Social and ethical considerations: Ethical issues raised by telehealth in the government sector include disparities in telehealth (and broadband) access, fiduciary duties of health care providers, privacy, equity, and workforce concerns.

Volunteer/Consumer

For the purposes of this case study, the primary actors within the volunteer/consumer sector are patients and consumers accessing telehealth, including mHealth. It is important to keep in mind that many members of “the public” nationally and internationally never have the opportunity to be patients or consumers of emerging technologies, and so do not show up in the following analysis. These members of the public may nonetheless be affected by the development, deployment, and use of such technologies, and those impacts should be taken into account.

Science and technology: Prior to the COVID-19 pandemic, mHealth apps may have been most people’s primary experience with telehealth, as many of these apps are free or low-cost to download for iOS and Android phones (Friedman et al., 2022). There is little data available on the safety and efficacy of many of these apps.

Governance and enforcement: Currently, there is little regulatory enforcement of many mHealth apps, though a number of mHealth devices have received FDA clearance.

Affordability and reimbursement: As noted previously, insurance coverage for telehealth has expanded dramatically in recent years, and particularly since the start of the COVID-19 pandemic. mHealth apps are free or low-cost to download, though they require that the consumer have a smartphone and internet access.

Private companies: These include mHealth app developers and companies like Apple and FitBit, offering direct-to-consumer health and wellness applications outside health care institutions and employee-sponsored wellness programs.

Social and ethical considerations: Potential drivers include adult children caring for aging parents at a distance, seeking the capacity to both monitor their parents’ health and safety and communicate with their parents’ health care providers; concerns about equity regarding access if Apple continues to expand in the mHealth space and Android continues to lag (more than half of U.S. smartphone owners have Androids, and Android users have a lower average income than iPhone users); and concerns about the use of mHealth devices/toys with children in regard to safety, efficacy, and privacy/data security (Comscore, 2014).

Ethical and Societal Implications

What is morally at stake what are the sources of ethical controversy does this technology/application raise different and unique equity concerns.

In outlining the concerns of the authors in terms of the use of this technology, we considered the following ethical dimensions, as outlined in the recent National Academies of Sciences, Engineering, and Medicine report A Framework for Addressing Ethical Dimensions of Emerging and Innovative Biomedical Technologies: A Synthesis of Relevant National Academies Reports (NASEM, 2019).

  • Promote societal value
  • Minimize negative societal impact
  • Protect the interests of research participants
  • Advance the interests of patients
  • Maximize scientific rigor and data quality
  • Engage relevant communities
  • Ensure oversight and accountability
  • Recognize appropriate government and policy roles

It is important to keep in mind that different uses of this technology in different populations and contexts will raise different constellations of issues. For example, telephone-based telehealth can be very different than video- or app-based telehealth, with different implications when used to serve urban, high-income adults versus rural, low-income children. Some of the specific concerns might include the following (Nittari et al., 2020):

  • Is the quality of care delivered via any given telehealth platform of comparable quality to in-person care? What is gained? What is lost?
  • How does a focus on efficiency or cost savings affect compassion/patient welfare? (Jacobs, 2019)
  • How is continuity of care affected by communication gaps or barriers between providers at a distance, the patient, a physically present clinical care team, mHealth applications, and documentation in the medical record?
  • Are there risks to safety associated with virtual physical exams and treatment?
  • What is the effect on the physician–patient relationship and the establishment of trust in the absence of any physical interaction?
  • What are the risks to patient privacy and confidentiality, particularly in mHealth, and how can they be mitigated?
  • What kind of access to and control over data produced by mHealth devices do patients/consumers have?
  • What are the proprietary interests over domains of fragmented patient data and how do they affect care?
  • How can governance address the blurring boundary between personal medical data, public health data, and monetized consumer data?
  • What ought the requirements be for content and documentation of informed consent for telehealth as a mode of care, and within telehealth, for example, for the transmission and processing of health data?
  • How should countries regulate telemedicine when telemedicine services and patients are split across jurisdictions? When the operation of devices is split across jurisdictions?
  • How will the changing global political climate likely affect the regulation of telemedicine?
  • What are the issues raised by telemedicine across state and national borders, including both ethical (e.g., lack of cultural awareness or familiarity) and legal (e.g., cross-jurisdictional credentialing, regulation, liability)?
  • What is the level of reliability and fidelity of data transmitted from mHealth devices?
  • Who, how, and with what permissions can various actors access, store, and use the vast amounts of data generated by various telehealth interactions?
  • How transparent and accountable are the algorithms used by commercial telehealth devices/apps, as well as the data collection, storage, and use by telehealth companies?
  • Which entities involved in telehealth are outside the “covered entity” for the purposes of HIPAA, and how do they collect, store, and use patient data?
  • Will a shift to telehealth increase or decrease the isolation and quality of life of historically underserved and marginalized populations, including the elderly, and others with visual, hearing, or cognitive impairments? What about caregivers managing a dependent’s telehealth participation?

Beyond Telehealth

mHealth “is at the swirling confluence of remote sensing, consumer-facing personal technologies, and artificial intelligence (AI)” (Sim, 2019). Currently, AI, wearable and ambient sensors, and other emerging technologies are being used in research and are able to suggest future possibilities, but these have not yet been realized in the market. AI, of course, brings with it a whole host of additional concerns related not only to the technical challenges, including reliability and explainability of autonomous systems but also significant ethical concerns, including those related to bias in training data leading to structural racism being replicated at scale with AI, trust, trustworthiness of systems, and so on. Smart homes, also in ascendance, hold potential in the telehealth space, but the potential health benefits (and risks) remain largely in the future.

As alluded to previously, it is possible to foresee numerous future scenarios regarding the evolution of telehealth. In an effort to probe the kinds of worries the authors have about the trajectories of emerging technologies, to expand the range of lessons learned from each case, and ultimately to “pressure test” the governance framework, the authors have developed a brief “visioning” narrative that pushes the technology presented in the core case 10–15 years into the future, playing out one plausible (but imagined) trajectory. The narrative was developed iteratively in collaboration with a case-specific working group, with additional feedback from members of CESTI. All reviewers are acknowledged in the back matter of this paper. Each narrative is told from a particular perspective and is designed to highlight a small set of social shifts that shape and are shaped by the evolving technology.

Telehealth Case Visioning Narrative

Perspective: A remote caregiver and digital health navigator dyad

It is 2035, and the home has become the preferred site for the receipt of most acute and non-acute medical services (labs, imaging, nursing visits, retail pharmacy) in the United States. Termed hospital-at-home (HaH), it is also the dominant model for non-ICU-level in-person care in much of the world. Although this care paradigm has been around for decades, the COVID-19 pandemic catalyzed this shift due to physical distancing requirements and fears among patients about contracting the virus within the hospital setting. Massive investments from the private sector into telemedicine platforms, coupled with technology advancements in AI-enabled remote monitoring, voice-activated medical devices, augmented reality, and sensors were also pivotal in this care transformation. Results from randomized controlled trials showed that the HaH was just as effective as the traditional hospital setting for a wide range of medical conditions, and with lower cost. However, the data on patient safety has been mixed thus far, with certain kinds of care episodes demonstrating clear reductions in adverse events while others result in poorer outcomes, often due to poor recognition of the need for escalation to emergency care (e.g., malignant bowel obstruction being mistaken for constipation). Hospital visits are increasingly limited to serious conditions that mandate an in-person work-up (e.g., biopsy for a cancer diagnosis) or procedural intervention (e.g., surgical procedure or cardiac catheterization).

Chronic Disease Management

Beyond increasing access to specialty providers (physicians, nurses, pharmacists, physical therapists), this new care paradigm revolutionized chronic disease management. Through “digital touchpoints,” providers were able to durably increase patients’ engagement with their own self-care and remotely manage the trajectory of chronic diseases at increasingly earlier time points. By leveraging ambient clinical intelligence tools (i.e., Internet of Medical Things [IoMT]), all data became re-imagined as health care data, including music preferences, voice pitch, communication logs, gait, step counts, and sleep patterns—a process known as digital phenotyping. In this new personalized care paradigm, conditions such as hypertension, diabetes, heart failure, and renal insufficiency were now managed prospectively and continuously as opposed to in a reactive and episodic fashion. Patients could now be managed within the context of their lives, and for many, this meant the ability to safely “age in place.” However, over time questions arose as to how the governance of emerging technologies intersects with the provision of care in the home. Specifically, issues regarding data standards, quality assurance, interoperability, oversight, bias, and transparency were yet to be definitively addressed in the context of care delivery. Whom should be held legally responsible in instances of harm due to erroneous automated diagnosis? How can the authenticity, accuracy, and integrity of such a wide variety of devices be reliably established?

Impact on Equity

Unfortunately, HaH in some cases led to a widening of existing equity gaps. This is because many of the infrastructural technologies were not developed through the lens of equity or cultural competency (e.g., to account for language barriers, vision/hearing/physical impairments, digital and health literacy, or other impacts of the social determinants of health). Non-English-speaking patients who were more than 80 years of age had tremendous difficulty engaging with this care model, as their communication preferences were more consistent with an in-person encounter. Although HaH uptake was relatively low in areas of high economic deprivation due to poor infrastructure and add-on device costs (smartphones and sensing equipment), great strides were made in improving access to rural communities, in step with investments in broadband and satellite internet service. For the first time, specialty care became available in many areas previously described as “medical deserts.” There was also growing recognition that HaH models implicitly exclude individuals experiencing unstable housing or homelessness.

Impact on the Health Care Workforce

The often ad hoc implementation of these virtual workflows sent prevailing levels of physician burnout soaring even higher due to the lack of clear practice guidelines, time to engage with the data and patient communication that these systems generate, and concerns for liability exposure. Lengthy wait times were reported in many urban areas, as physicians now had to manage two distinct clinic schedules (in-person and virtual). There was also considerable displacement of many health care provider roles due to automation and the transition to HaH. Custodial staff, nursing assistants, clerical workers, and some administrative staff roles were transitioned out of the traditional medical infrastructure and into caretaker or home health worker roles. For those “essential health care workers” such as nurses and physicians, retraining was set in motion by credentialing bodies to ensure that fluency in statistics, data science, and information systems became core competencies, allowing these workers to remain relevant and effective in the new digital age. Rote memorization of medical facts was no longer the norm in medical schools. A stronger emphasis was also placed on the human skills that cannot be displaced with automation such as empathy, physical examination, and implicit bias awareness. New health care roles also emerged in this data-rich delivery paradigm, such as digital health navigators, telenurses, and health data specialists. However, many of these new positions and several traditional ones (e.g., physicians, nurses, care coordinators) were increasingly outsourced to global vendors in an attempt to reduce the administrative costs of health care. In this distributed staffing model, international hubs of excellence also began to emerge for certain conditions or treatments (e.g., Sweden for the best interpretation of radiology images). With this in mind, the broader question of how to appropriately regulate remote second opinions across international borders arose. What licensure requirements should be enforced for the practice of international telemedicine? In an increasingly networked world, do state-based licensures still make sense? Calls for the nationalization of medical licensure, or at a minimum the harmonization of requirements across states, were proposed by a variety of stakeholders.

Data Privacy, Trust, and the Wisdom of Crowds

Mr. Jeff Jackson is a 63-year-old Black male with hard-to-control type 2 diabetes, early-onset Alzheimer’s disease, and stable chronic heart failure (CHF). He has chosen to live alone in Youngstown, Ohio, since his wife died 5 years ago. An implanted microchip is able to sample, interpret, and transmit biometric (heart rate, temperature, oxygen saturation) and biochemical data (blood glucose, sodium levels, creatinine levels) about Mr. Jackson at high frequency. AI algorithms embedded within wall-mounted camera-based sensors are also able to detect the progression of his Alzheimer’s or warning signs of acute exacerbations of his CHF. All of this information is relayed 24/7 to a “digital health navigator” assigned by his health plan who serves as a health coach and care coordinator. As outlined in the consent agreement, monthly summaries of routine care are sent to his 23-year-old daughter, Jean, who resides in Miami, Florida. Potentially concerning events sensed in Ohio automatically trigger real-time “red alerts” to both the digital navigator and Jean. Arrangements like this raised many questions during their rollout, including but not limited to the potential vulnerability of these technologies to data breaches and cyberattacks, particularly since the identifiable medical record of every U.S. patient was transitioned to the cloud to facilitate interoperability and timely access. Should HIPAA include the home digital infrastructure in its scope? Under what circumstance should employers or insurance companies have access to personal data? What should be the recourse for care episodes involving harm due to egregious digital navigator negligence? Lastly, instances wherein elder or child abuse or domestic violence were detected using camera-based sensors (“bycatching”) raised ethical concerns as to whether the gravity of these offenses justified circumventing the confidentiality, privacy, and anonymity of involved patients and family members. These events also give rise to the broader question of who owns or is able to repossess these data. Will commercial entities be able to contract and monetize passively captured (audio or video) personal information (e.g., targeted advertising on social media based on fridge contents)?

About 6 months ago, based on his personality traits, risk preferences, and at the strong suggestion of his daughter, Jeff joined a health platform called “All2Gether” that linked individuals across the globe based on more than 200 phenotypes. The goal was to provide phenotype-specific social support to reduce loneliness. The platform offered crowd-sourced medical advice based on lived experiences, behavioral change interventions, and in some instances, mental health therapies based on biofeedback techniques. The much-heralded age of “democratizing medical knowledge” had finally arrived, with these platforms now able to serve millions of people worldwide and drive robust engagement. Over time, Jean had grown much more comfortable entrusting her father’s health data to these cloud-based platforms, rather than a primary care physician or the digital health navigation company. For Jean, this mistrust in her father’s primary care physician and the digital health navigation company was undergirded by the fact that neither she nor Jeff had direct access to the raw data or proprietary algorithms that informed his care. Conspiracy theories and science denial began to rapidly proliferate on these platforms, casting doubt on the value of long-established medical treatments and entrenching health care mistrust. This accelerated in some quarters, a rejection of digital therapeutics and data-driven medicine all together, in favor of more relationship-based approaches to health care.

The international reach of these companies also made regulatory oversight difficult because the practice of medicine is usually controlled through state-specific licensure. Legal experts pointed out that these international platform companies are often predatory and in violation of the existing corporate practice of medicine. Proponents argue that these companies are not “health services establishments” and their business model does not constitute a “provider–patient relationship,” in fact, they claim it is no different from a patient-initiated search engine query. Furthermore, for many patients in rural areas and parts of the developing world, these platforms are the only portal to timely and affordable medical advice. All of these issues are illustrative of the fact that many of the normative behaviors and standards around the practice of medicine evolved well before the information boom associated with the internet and digital care transformation catalyzed by the COVID-19 pandemic.

Telehealth Case Study: Lessons Learned

Some lessons drawn from the above core case and visioning exercise that can inform the development of a cross-sectoral governance framework for emerging technologies focused on societal benefit are given below.

  • The coexistence of health and non-health (e.g., wellness) applications can complicate governance.
  • It is important to keep in mind the dual roles of state and federal regulation, as well, potentially, of regional (e.g., European Union) regulation.
  • There are opportunities for shared or distributed governance in the gaps between regulatory authorities.
  • There is a potential role for cross-sectoral governance groups at multiple levels and stages of governance.
  • It is important to keep in mind the role of key enabling technologies (e.g., internet access and speed) in the development of the primary technology of interest.
  • Key stakeholders to a technology will need to be adequately prepared for large shifts (e.g., dramatic ramping up of telehealth).
  • Opportunities for regulatory nimbleness have been revealed by the federal response to the COVID-19 pandemic (e.g., steps skipped).
  • Attention must be paid to the equity implications of access (or lack thereof) to enabling technologies.
  • Attention should be paid to identifying and assessing the impact of intangible losses (e.g., healing touch, patient–provider relationships).
  • Despite an explicit focus and justification for telehealth based on concerns about equity and access, success has been mixed—improving access in some cases and recapitulating existing inequities in others.
  • Special attention must be paid to technologies requiring collection, storage, and use of human data.
  • As the degree to which our lives are lived online versus in-person, we can become increasingly alienated from our normal markers of trust.
  • We lack appropriate governance tools for a health care delivery landscape that is becoming increasingly digital and international.
  • We may need to reconsider the traditional risk/benefit analysis of health care treatments when the opportunity for “immediate rescue” in situations of acute decompensation, no longer exists due to physical distance.
  • One person’s valued benefit is another person’s harm (and vice versa) (e.g., home monitoring for safety versus surveillance).
  • In order to adequately assess the risk/benefit balance, we need to make the trade-offs explicit (e.g., gains in convenience versus loss of privacy).
  • We need both ethics and governance frameworks for addressing instances of “bycatching” (e.g., elder abuse captured via camera-based sensors).
  • Technology (beyond traditional social media) can drive or erode trust in medical expertise (e.g., dissemination of false information about available treatment options on online platforms).
  • There is flexibility/lack of oversight in the grey area that exists following the development of promising data regarding a new technology, but before proven efficacy and regulated products; this lack of oversight can drive innovation and investment in emerging technologies or delivery models, but also comes with risks.
  • In the digital home, there are no silos around work/personal or public/private. What happens when the same living environment has to pivot from a place of rest to a place of work (remote work) to a place to get care (hospital-at-home)?

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https://doi.org/10.31478/202311e

Suggested Citation

Mathews, D., A. Abernethy, A. J. Butte, P. Ginsburg, B. Kocher, C. Novelli, L. Sandy, J. Smee, R. Fabi, A. C. Offodile II, J. S. Sherkow, R. D. Sullenger, E. Freiling, and C. Balatbat. 2023. Telehealth and Mobile Health: Case Study for Understanding and Anticipating Emerging Science and Technology. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. https://doi.org/10.31478/202311e .

Author Information

Debra Mathews, PhD, MA, is Associate Director for Research and Programs at the Johns Hopkins Berman Institute of Bioethics and Professor, Department of Genetic Medicine at the Johns Hopkins University School of Medicine. Amy Abernethy, MD, PhD, is President of Product Development and Chief Medical Officer at Verily. Atul J. Butte, MD, PhD, is Priscilla Chan and Mark Zuckerberg Distinguished Professor at the University of California, San Francisco. Paul Ginsburg, PhD, is Professor of the Practice of Health Policy and Management at the University of Southern California and Senior Fellow at the USC Schaeffer Center. Bob Kocher, MD, is Partner at Venrock. Catherine Novelli, JD, LLM, is President of Listening for America. Lewis Sandy, MD, is Principal and Co-founder, Sulu Coaching. John Smee, PhD, is Senior VP Engineering at Qualcomm Technologies, Inc. Rachel Fabi, PhD, is Associate Professor, Center for Bioethics and Humanities at SUNY Upstate Medical University. Anaeze C. Offodile II, MD, MPH, is Chief Strategy Officer at Memorial Sloan Kettering Cancer Center. Jacob S. Sherkow, JD, MA, is Professor of Law at the Illinois College of Law, Professor of Medicine at the Carle Illinois College of Medicine, Professor at the European Union Center, and Affiliate of the Carl R. Woese Institute for Genomic Biology at the University of Illinois. Rebecca D. Sullenger, BSPH, is a medical student at the Duke University School of Medicine. Emma Freiling, BA, is a Research Associate at the National Academy of Medicine. Celynne Balatbat, BA, was the Special Assistant to the NAM President at the National Academy of Medicine while this paper was authored.

Acknowledgments

This paper benefitted from the thoughtful input of Bernard Lo , University of California San Francisco; and George Demiris , University of Pennsylvania.

Conflict-of-Interest Disclosures

Amy Abernethy reports personal fees from Verily/Alphabet, relationships with Georgiamune and EQRx, and personal investments in Iterative Health and One Health, outside the submitted work. Atul J. Butte reports support for the present manuscript from National Institutes of Health; grants or contracts from Merck, Genentech, Peraton (as a prime for an NIH contract), Priscilla Chan and Mark Zuckerberg, the Bakar Family Foundation; royalties or licenses from NuMedii, Personalis, and Progenity; consulting fees from Samsung, Gerson Lehman Group, Dartmouth, Gladstone Institute, Boston Children’s Hospital, and the Mango Tree Corporation; payment of honoraria from Boston Children’s Hospital, Johns Hopkins University, Endocrine Society, Alliance for Academic Internal Medicine, Roche, Children’s Hospital of Philadelphia, University of Pittsburgh Medical Center, Cleveland Clinic, University of Utah, Society of Toxicology, Mayo Clinic, Pfizer, Cerner, Johnson and Johnson, and the Transplantation Society; payment for expert testimony from Foresight, support for attending meetings and/or travel from Alliance for Academic Internal Medicine, Cleveland Clinic, University of Utah, Society of Toxicology, Mayo Clinic, Children’s Hospital of Philadelphia, American Association of Clinical Chemistry, Analytical, and Life Science & Diagnostics Association; patents planned, issued, or pending from Personalis, NuMedii, Carmenta, Progenity, Stanford, and University of California, San Francisco; participation on a Data Safety Monitoring Board or Advisory Board from Washington University in Saint Louis, Regenstrief Institute, Geisinger, and University of Michigan; leadership or fiduciary role in other board, society, committee or advocacy group, from National Institutes of Health, National Academy of Medicine, and JAMA; and stock or stock options from Sophia Genetics, Allbirds, Coursera, Digital Ocean, Rivian, Invitae, Editas Medicine, Pacific Biosciences, Snowflake, Meta, Alphabet, 10x Genomics, Snap, Regeneron, Doximity, Netflix, Illumina, Royalty Pharma, Starbucks, Sutro Biopharma, Pfizer, Biontech, Advanced Micro Devices, Amazon, Microsoft, Moderna, Tesla, Apple, Personalis, and Lilly. Paul Ginsburg reports personal fees from the American Academy of Ophthalmology outside the submitted work. Bob Kocher reports being a Partner at the venture capital firm Venrock which invests in technology and healthcare businesses. Dr. Kocher is on the Boards of several healthcare services businesses that utilize telehealth technology including Lyra Health, Aledade, Devoted Health, Virta Health, Accompany Health, Sitka, Need, and Candid. Jacob S. Sherkow reports employment with the University of Illinois, grants from National Institutes of Health, personal fees from Expert Consulting services, outside the submitted work.

Correspondence

Questions or comments should be directed to Debra Mathews at [email protected].

The views expressed in this paper are those of the authors and not necessarily of the authors’ organizations, the National Academy of Medicine (NAM), or the National Academies of Sciences, Engineering, and Medicine (the National Academies). The paper is intended to help inform and stimulate discussion. It is not a report of the NAM or the National Academies. Copyright by the National Academy of Sciences. All rights reserved.

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