The regulatory landscape for digital health applications must be reformed


When people are looking for health information, they expect it to be reliable and accurate. But those expectations can be dashed, especially by digital health devices, many of which are not reviewed by the Food and Drug Administration or other regulatory body.

Here are some examples from the medical literature and current events:

John has bipolar disorder. He downloads a few apps to help him manage and track his symptoms. During a manic phase, John has trouble sleeping, so he turns to apps for advice. One of them tells her to “have a drink of alcohol” an hour before bed. The other informs him that his bipolar disorder is contagious and can be caught by people spending too much time with him.


Linda has type 1 diabetes and downloaded a free app to help him calculate his insulin dose. After following her recommendation, she suffers from severe hypoglycemia, which could have been avoided with precise application. She is one of the quarter of app users who have reported incorrect results from the calculation of the insulin dose of the application.

Nancy uses a pregnancy tracker app that she got through her employer’s wellness program. After giving birth to her first child, she used it to record her baby’s personal health data. Now that she is pregnant with her second child, she uses the app to track her bodily functions, medications and sex drive. Although she expects this information to be private to her, her employer has paid to obtain aggregate data about her employees using the app.


Although John, Linda, and Nancy are not real people, the advice from the apps and their health and privacy risks are real. These three vignettes show just how dangerous inaccurate digital health apps can be. There are countless examples – of rule tracking apps offer incorrect clinical information to applications using artificial intelligence algorithms misdiagnose people of color with skin cancer.

The increasing use of digital health products in recent years has led to a patchwork of laws and regulations with serious weaknesses. The FDA regulates some of these products as medical devices, but the majority of applications intended to be used only to monitor and record symptoms – and not to treat disease – are unregulated. Many other applications are considered low risk by the FDA and therefore are subject to enforcement discretion, meaning the FDA effectively chooses not to enforce its authority over these devices. As described earlier, this can put users at risk.

Another problem is that the iterative nature of digital health applications does not lend itself to existing regulatory paradigms. Medical knowledge and advice can change quickly, as we saw during the Covid-19 pandemic, and apps require frequent updates. But the FDA regulates and approves the devices as end products. While it largely allows – and sometimes requires – post-market studies, it does not easily anticipate the frequent post-approval updates and changes required for software, artificial intelligence algorithms, and clinical guidelines.

In addition, certain aspects of concern to users of digital health applications, such as privacy and usability, fall outside of traditional FDA scrutiny and may not be considered by other agencies or companies in the process. the development or review of such applications.

4 key indicators for digital health applications

the concept Digital health applications provide a great opportunity for individuals to take control of their own health care, but their reality leaves a lot to be desired. The current regulatory landscape for digital health applications needs to be reformed.

Since fall 2020, together with a team of 19 student researchers from Yale Schools of Business, Law, Medicine and Public Health, we have reviewed the literature on digital health applications and met with patient groups. and patient advocates. From this work, we have developed a user-centric approach which should guide the development of an effective regulatory system for digital health applications that focuses on improving four key metrics: accuracy, usability, accessibility and privacy. Although not all are regulated by federal law Food, Drugs and Cosmetics Act, they are nonetheless an integral part of successful regulation and should be considered as part of broader digital health regulatory reform. The four principles we propose are:

  • Precision. Digital health applications must be accurate, reviewed for accuracy and reveal areas of inaccuracy.
  • Friendliness. Digital health applications must be usable and understandable for users.
  • Accessibility. Various groups should be included in the development and review of digital health applications to promote accessibility for all users.
  • Privacy. Users’ private information must be protected and they must be able to turn key privacy options on and off.

While it may seem simple and straightforward, the current regulatory environment does not adequately protect users of digital health applications in these areas. Many are inaccurate, which exposes users to negative results. User needs and preferences are usually not taken into account in application development, which limits their ease of use and causes many users to stop using the applications after the first a few weeks. The needs and preferences of various users are not included in the development of many digital health applications, especially artificial intelligence algorithms, which limits their effectiveness and accessibility for many people of color, people with disabilities and others. people with limited or no proficiency in English. And many healthcare apps do not have a privacy policy and do not adequately protect user data, resulting in many notable healthcare data breaches.

While the FDA recently took steps to begin regulating digital health technologies, including establishing a pilot program and one Center of excellence, a lot of work remains to be done. Overall, the FDA needs more resources and authority to regulate and review digital health applications.

As Congress, FDA, industry, patients, providers, and other stakeholders strive to develop an appropriate pathway for digital health applications, we must ensure that the system keeps the needs of users. on your mind.

Ryan Knox is a lawyer, health policy specialist, and senior researcher at the Solomon Center for Health Law and Policy at Yale Law School. Cara Tenenbaum is a health policy expert and owner of Strathmore Health Strategy.