Can Patient-Generated Data Help Regulate Medical Devices?

Troy Brown, RN

November 16, 2018

The Patient Engagement Advisory Committee (PEAC) of the US Food and Drug Administration (FDA) met yesterday to discuss ways the FDA can use patient-driven platforms — including social media, digital health technology, and patient registry data — to gather and evaluate real-world data and assist with regulatory evaluation of medical devices.

People are increasingly going online to locate and share health information. In addition to seeking advice from healthcare professionals on educational websites, people also find value in virtual patient communities where they can share health experiences and receive feedback from one another.

Such patient-driven platforms provide a great deal of patient-generated health data, which could contribute to real-world evidence to safeguard public health and facilitate healthcare innovation.

The group met to discuss whether such patient-generated data provides accurate information (fit-for-purpose) to be used in postmarketing studies of medical devices

The PEAC is the first FDA advisory committee focused entirely on patients and issues related to patients. The panel members include patient representatives, a consumer representative, and a non-voting industry member chosen on the basis of the topic. The committee advises FDA Commissioner Scott Gottlieb, MD, on complicated issues regarding medical devices, the regulation of such devices, and patient use of the devices.

Technology Pros and Cons

Some people are squeamish about giving away their private data, several panelists said.

"I'm not so sure that it's the government coming to ask you to give your health data to a registry or something; it's more likely to be the sponsor for a medical device that's doing a postmarket study and that's a different thing. I think it's really important that data outlives the sponsor somehow, and how to do that is beyond me," committee member Bennet R. Dunlap, MS, Health Communication Consultant, Diabetes Patient Advocacy, said at the meeting.

"[W]e need to make sure that we are not expecting technology to give us a magic bullet, or a silver spoon solution…because the messages that I've heard about social media today tell me there's an enormous amount of information there; it may or may not be 'valid data' and it will never eliminate the need for sound analysis by people," committee member Deborah Cornwall, MBA, from the Corlund Group LLC, said at the meeting.

"I think we just need to make sure we're not setting our own expectations higher than it is reasonable to set them, but that we are adapting to what is feasible and recognizing the pros and cons of what we can get and the need for human analysis to give it meaning," Cornwall added.

Along with the benefits of using patient-generated health data, there are challenges as well.

Study results may not reflect the true outcomes, as a result of mistakes made when choosing the study population, designing the study, or analyzing the data. The quality and integrity of data may also be faulty, with issues including missing data, duplicated patients, fake patients, and data manipulation.

In addition, the study results may not be generalizable to all patients living with the condition; there may be other considerations unique to patient-generated health data that were not recorded; and there may be problems associated with social media, sensor-related data, and patient-driven registry data.

Trust between the patient and vendor or government is crucial, committee chair Paul T. Conway, American Association of Kidney Patients, explained at the meeting. One way of maintaining that trust is "the continued and expanding use of patient organizations to collect data. One of the items mentioned was socioeconomic backgrounds and whether or not there are disparities in the data that's collected and applied," Conway said.

Patient Privacy Critical

Several committee members mentioned the importance of patient privacy.

Tactics for identifying individuals with certain medical conditions and those who are underrepresented in clinical trials for medical devices include using internet-connected digital health technology and social media.

"I think the internet-connected digital technology, health technology is good to be used for identifying and recruiting patients for studies; I think the privacy issues with this approach to clinical recruitment should be specific for the study," committee member Monica Parker, MD, Emory Alzheimer's Disease Research Center, Emory University, said at the meeting.

Parker and other panel members said informed consent should be written, easy to understand, and explain all of the possible uses of the patient's information, including medical research.

Wide Range of Communication Avenues

A number of panel members mentioned using the FDA website, Facebook posts, YouTube, blogs, Twitter, and email blasts to subscribers as ways of disseminating information about medical devices. Others also suggested television, radio, and public service announcements.

Many people at the meeting felt excited by all of the innovation discussed, Katherine D. Seelman, PhD, professor emerita (retired), University of Pittsburg, School of Health and Rehabilitation Sciences, Department of Rehab Science and Tech, Science, Technology, & Public Policy, told the group.

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