The Patient Engagement Advisory Committee (PEAC) to the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH or Center) met on 15 November 2018. The meeting topic was entitled "Connected and Empowered Patients: e-Platforms Potentially Expanding the Definition of Scientific Evidence." At the meeting, the PEAC discussed and made recommendations on how CDRH can use and take advantage of patient and consumer-generated health data, such as from social media, medical device sensors and patient-driven registries, in the Center's regulatory activities.

Among other things, the PEAC recommended that, in carrying out post-market regulatory activities, patient and consumer-generated health data should be used to inform decision making in these activities. These activities include: advising manufacturers on the development of post-market studies (such as defining the study design, patient population, and outcomes of interest); performing surveillance for adverse events; issuing recalls, and communicating product safety "signals" (device-related concerns) to the public.

The PEAC also agreed that CDRH (and FDA more generally) needs to take the following steps: standardize how data are collected, used and applied in the various situations; ensure the language used to communicate to patients and healthcare consumers, about how the data being collected will be used, is clear and understandable; ensure the data collected are de-identified (with appropriate privacy controls); and ensure a high level of data integrity when the data are collected.

The PEAC also provided feedback on potential obstacles that exist to using patient and consumer-generated health data in regulatory decision making. The obstacles include: the possibility that results obtained from the data do not reflect the true outcomes; data quality and integrity issues; and the potential inability to account for confounding factors.

The PEAC also agreed that, while the FDA is making progress with regard to effectively utilizing patient and consumer-generated health data, more still needs to be accomplished, triggering the PEAC to make the following additional recommendations to CDRH in this area:

  • Build more trust between stakeholders (patients, industry, vendors and the government);
  • Consider differences in access and use of certain technologies, such as sensors and smartphones, due to socioeconomic factors;
  • Encourage the involvement of patient organizations in the collection of the desired health data;
  • Ensure that patients are educated in clear terms on how to use their devices and on how the data are being collected;
  • Ensure that the desired health data comes from true and not "fake" patients; and
  • Develop standard data content elements and formats in which data are collected and reported for uniformity purposes.

The PEAC also discussed how digital health technology and social media could be used to identify people living with certain medical conditions and under-represented populations for inclusion in medical device clinical studies. However, the PEAC also encouraged the identification of under-represented patients by frequenting places they normally would visit in their daily life as opposed to relying solely on social media to identify them.

Among others, additional points of emphasis by the PEAC included:

  • CDRH should set a regulatory framework for what constitutes usable types of data for clinical trials and for purposes of other types of regulatory decision making;
  • CDRH should develop standards around patient consent to data collection, I.e., to what they are consenting, consent duration, ability to access their own data, consent rescission, etc.;
  • FDA should use social media as a means to encourage and drive data collection and not just to mine the data on social media as posted;
  • Patients should have access to their data to use and share;
  • FDA should use its website, Facebook, YouTube, email blasts to subscribers, blogs, Twitter, and webinars, and should leverage patient organizations, to communicate information about medical devices; and
  • FDA should refine its website to make it more user friendly and easier for the user to find content.

The existence of the PEAC reflects the growing voice of patients and healthcare consumers in the Agency's regulatory decision making processes for medical devices. While this alert focuses on CDRH and medical devices, the increasing voice of patients and healthcare consumers is broad and extends to other FDA regulated articles as well, e.g., pharmaceutical drugs and biological drug products.

CDRH now acknowledges that increasingly patients and healthcare consumers are using social media and other web platforms to share their health experiences and to seek information from other patients and consumers. The Center realizes that the exchange is no longer just between the patients and their healthcare providers.

It will behoove FDA-regulated medical device companies to keep abreast of and pace with FDA initiatives on patient engagement and use of patient and consumer-generated health data in regulatory decision making and to institute their own mechanisms to collect, organize and utilize such data in ways consistent with FDA expectations. The FDA regulatory importance of these data will only grow over time.

If you have any questions concerning FDA initiatives on patient engagement and use of patient and consumer-generated health data in regulatory decision making, please feel free to contact us.

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