Customizing the Sharing of Health Data

The ecosystem benefits when people have more than just ownership of their health data.

This 2017 holiday season, fitness trackers and genetic testing kits flew off the virtual shelves. We are entering a time when our physical, digital and biological spheres are merging, a concept that has been called “the 4th Industrial Revolution”, and healthcare and clinical research are at a critical point of evolution. New technologies enable the collection of deeper and wider datasets that hold the promise of surfacing new insights into the biology and behavioral genesis of health and disease.

We are simultaneously experiencing a paradigm shift, championed by Dr. Eric Topol, Linda Avey and others, in our understanding of health data ownership. Cultural expectations, bolstered by the law, are leading us to an understanding that individuals own and should control their health information.

While organizations and advocates collectively work on this quest, we also must consider that access and control is not enough. For people and their families, there is a range of personal capabilities and motivations to actively engage in the full spectrum of their health information. For those of us who provide clinical care and conduct research there is an obligation to consider the preferences of the patient or research participant and to make this information meaningful. In addition, the vast majority of people receive care through general practitioners or specialty clinicians in health systems, and if a result triggers a clinical concern it will be critical to coordinate the communication of information.

Consumer-facing devices have begun to move in the direction of offering curated health data, characterizing general health status of an individual through a few physiological measurements. Much will be learned from the experience of returning information in the consumer environment focused on maintenance of health. At the same time, clarification of people’s right to their health records has led to a requirement that electronic health records are accessible through a portal, with penalties for not doing so. This will provide another source of learning about how to share information that was previously considered the private purview of doctors and health systems.

Verily is engaged in Project Baseline, which is stretching beyond previous boundaries to create a biomedical information system that can measure the spectrum from biomolecular (as in genetics), clinical (including imaging, lab testing and health outcomes), behavioral, social and environmental data (collected through sensors, wearable devices like watches and cell phones). Working in partnership with participants in North Carolina and California to start, we are developing this system through detailed measurement of a diverse population. As we address the return of results beyond health maintenance or clinical care into research measurements, we are aware of the challenge and opportunity to share results in a way that comports with participants’ capabilities and wishes as well as with those who care for them. And there are a lot of results to parse – over 6 terabytes of data generated in the first 2 days of an individual’s participation in the study.

In order to return the data that participants offer back to them, the experience must be meaningful. We are exploring ways to do this in a manner that does not create unnecessary anxiety or concern, and that helps people take appropriate, timely action ultimately enhancing the relationship between study participants and their clinicians.

Take my specialty of cardiovascular medicine. In the Project Baseline study we are doing an echocardiogram in the first 1000 participants. This detailed image of the heart produces hundreds of complex measurements and holds the promise of new knowledge by integrating the image interpretation with the other detailed measurements. Only a small proportion of Baseline participants would want the detailed summary, and many “abnormalities” are common and require no clinical intervention. In other cases we may discover an abnormality that most clinicians agree require the most serious type of medical intervention, such as valve surgery. These results from our study are not in the context of a clinical test ordered for a specific reason and putting results in context often requires interaction with a clinician.

Project Baseline is on the cutting edge of these issues. We will be adapting and learning as we go, but the principles of personal right to information and partnership in the joy of research discovery with research participants, their families and communities are guiding lights in our journey. But we are also highly attuned to the need to work on this partnership with sensitivity to the needs, well-being and preferences of participants. The combination of the human skills and technology of Verily, our academic partners and the research participants themselves should create a roadmap for personalization of return of results.

We will be discussing what we are learning and debating the path forward at South by Southwest’s Empowering people to own their health data this Saturday, March 10 at 9.30am and welcome comments as we learn how to navigate this exciting change in our view of health and the use of information to maintain it.

Posted by Robert Califf, MD; Advisor, Verily; Vice Chancellor for Clinical and Translational Research, Duke University; Former Commissioner, US Food and Drug Administration

This post is also available on Medium.