Where Will Our New Digital Health Policies Lead Us?

By Kathryn Coburn, Section of Science and Technology Law - American Bar Association

I’m thinking about where we’re headed in digital health. Where will our new digital health policies lead us? 

Many federal regulations are being significantly modified to encourage and foster innovations in digital health. Witness the U.S. Food and Drug Administration's (FDA) new digital health policies. The FDA knows that consumers who are better informed about health take steps to improve their health choices and often have better outcomes. So the FDA issued a new Digital Health Action Plan. It announced the FDA Entrepreneurs-in-Residence program and its new Digital Health Pre-Certification program, along with three new regulatory Guidances that offer more clarity about where the FDA no longer sees a need to be involved, which products no longer qualify as medical devices subject to FDA oversight and also, how the FDA will evaluate Software as a Medical Device, going forward.

On January 18, 2018, Health and Human Services’ (HHS) Common Rule (Federal Policy for the Protection of Human Subjects) went into effect. The purpose of the Common Rule is to protect human subjects involved in research, while facilitating valuable research and reducing burden, delay and ambiguity for investigators. The new Common Rule removes many regulatory obstacles to the advancement of Precision Medicine, including obstacles to the creation of very large datasets obtained from electronic health records and other digital data.  Among the major changes in the Final Common Rule are the permissible use of “broad consent” (seeking prospective consent to unspecified future research) from a subject, for storage, maintenance and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative to conducting research on nonidentified information and nonidentified  biospecimens, IRB consent waivers of consent or consent for a specific study.

The FDA states that the purpose of its pre-Certification Program is to balance the reduced time and cost of market entry for digital health against the need for patient safety and quality of care.  This will require significant ongoing input from the stakeholders in digital health, including manufacturers, suppliers, consumers and clinicians.

Many questions come to mind. These questions will have to be considered if we are to obtain the benefits of AI, while averting potential negative outcomes.

How much transparency should be available to the clinician?  How much transparency should be available to the user?   What factors are considered by the AI device when it makes decisions?  Why these factors used and what are the desired outcome?  Are the factors used for decision-making sufficient or should others be included?  What information is collected by the device? Where is that information routed? Who is responsible and liable if things go wrong?  Who is responsible for monitoring the device?  Is the monitoring continuous?  Are the algorithms that are used in the device based on ethical and accurate assumptions? Is the AI device going to act consistent with medical and healthcare standards?  Which healthcare standards will the device apply?  Have the users received training on the device to ensure that it is used correctly?

These are questions for all of us. One day every one of us will be receiving health information and/or deciding on medical treatments involving AI.

Want to learn more? Register for the session at HIMSS18:
Meeting the Challenges of Digital Medicine