Power to the Patient with Patient Generated Health Data

FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.  The workshop included many sessions and panel discussions that focused on how PGHD can be used in patient care and clinical studies to improve health equity.   The benefits of PGHD, challenges with PGHD, and future of PGHD were discussed by FDA representatives, industry representatives, patient organizations, and patients.

Patient-generated health data are data that are created, recorded, or gathered by patients or caregivers outside of a clinical setting.  PGHD can be derived from Digital Health Technologies, which we have blogged on here, here, and here.  Examples include measuring activity levels with wearables, recording symptoms with mobile applications, and collecting biometric data, such as blood pressure, with medical devices.  PGHD can be used as part of patient care as well as in clinical trials.  In clinical trials, PGHD can be used in clinical outcome assessments (COAs) that describe how a person feels, functions, or survives, which can be valuable endpoints.

One highlight of the workshop was that what matters to regulators, providers, and payors may not align with what matters to patients.  It was also noted that patient-generated data does not always mean patient centered data, meaning that while a patient may be involved in data collection, the data may not be meaningful to them. There is also a connotation that patient-generated data is lower quality and not as reliable, but with current technology, data that are meaningful to patients with high quality and reliability are possible.

Patients want to feel better, have more energy, have the ability to work, and take fewer medications.  Using PGHD can help patients manage their own health and can help sponsors develop endpoints for studying impacts of new treatments that matter to patients.  One patient, who is also a scientist, shared their journey with cancer and how personal use of wearables and over-the-counter medical devices during treatment was able to show correlation between the data they collected and the days they were feeling good and bad.

Patients that spoke also noted that they felt empowered, rather than merely passive recipients of medical services, when PGHD was part of their healthcare or when participating in studies using PGHD.  Another patient shared their journey with diabetes.  This patient had used wearable devices on their own in the past but did not understand how to use the data to manage their health.  When they were prescribed a continuous glucose meter and insulin pump, use of technology as part of their prescribed treatment plan improved both their physical and mental health dramatically and allowed them to go from 11 medications to just insulin.

From the patient’s perspective, security and privacy were identified as key issues by some, but for others, they are so focused on their health that they aren’t necessarily thinking about this, even though it may be very important.  It was noted that many patients don’t understand digital consent, what data they are providing, and for what purpose.  Patients also don’t have the opportunity to make changes to the consent to ensure they are comfortable with the use of their data.

Sponsors need to make sure patients and study participants can use the technology.  It was noted that keeping the cost of wearables low will help with equity, especially in use of PGHD outside of clinical studies.  Where technology is used to generate PGHD for clinical trials of other medical products, sponsors may need to provide WiFi and/or phones to study participants if what the patient has will not meet requirements to avoid excluding patients.

As for the future of PGHD, many panelists were asked how they envision use of PGHD in 2030.  Responses included use of PGHD in risk prevention and avoidance, allowing studies to proceed without placebo, referencing PGHD as just “data” and not “digitally derived,” and having patient experience data collected and taken into account in every study, regulatory, and coverage decision – ultimately a shift to give power to patients.

As this post shares only a few highlights from the enlightening two-day workshop, readers can access more information on CDRH’s and DiMe’s websites.