FDA Launches Patient Engagement Advisory Committee | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

FDA Launches Patient Engagement Advisory Committee

September 24, 2015
by Heather Landi
| Reprints

Last week, the Food and Drug Administration (FDA) announced the creation of a Patient Engagement Advisory Committee (PEAC) to advise the FDA Commissioner on complex issues relating to medical devices, the regulation of devices and their use by patients.

In a blog post announcing the PEAC, Nina Hunter, Ph.D., a regulatory scientist in the FDA’s Center for Devices and Radiological Health, said the PEAC will “give FDA the opportunity to obtain expertise on various patient-related topics, with the goal of improving communication of benefits and risks and increasing integration of patient perspectives into the regulatory process.”

“Some questions that the PEAC may discuss include where and how best to engage patients across the device development and assessment lifecycle as well as how FDA and sponsors should communicate patient preference information to patients. The PEAC represents a new and exciting opportunity to foster patient partnerships with FDA, and it complements other efforts at FDA to bring the patient into the medical device regulatory process,” Hunter stated. Hunter also serves as a special assistant to Robert Califf, M.D., the FDA’s Deputy Commissioner for Medical Products and Tobacco.

According to the FDA announcement, the PEAC may consider topics such as agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, patient reported outcomes and device-related quality of life or health status issues, and other patient-related topics.

The PEAC will provide relevant skills and perspectives, in order to improve communication of benefits, risks, clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices, the FDA statement said. And, the PEAC will also provide advice and recommendations in areas such as identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers and identifying unintended consequences that could result from FDA policy.

“We are entering an era of ‘patient-centered’ medicine in which patients and their care partners participate actively in decision-making and priority-setting about all aspects of health care,” Hunter wrote. “FDA believes that patients can and should bring their own experiences to bear in helping the Agency define meaningful benefits or unreasonable risks for certain new devices.”

Topics

News

Former Health IT Head in San Diego County Charged with Defrauding Provider out of $800K

The ex-health IT director at North County Health Services, a San Diego County-based healthcare service provider, has been charged with spearheading fraudulent operations that cost the organization $800,000.

Allscripts Touts 1 Billion API Shares in 2017

Officials from Chicago-based health IT vendor Allscripts have attested that the company has reached a new milestone— one billion application programming interface (API) data exchange transactions in 2017.

Dignity Health, CHI Merging to Form New Catholic Health System

Catholic Health Initiatives (CHI), based in Englewood, Colorado, and San Francisco-based Dignity Health officially announced they are merging and have signed a definitive agreement to combine ministries and create a new, nonprofit Catholic health system.

HHS Announces Winning Solutions in Opioid Code-a-Thon

The U.S. Department of Health and Human Services (HHS) hosted this week a first-of-its-kind two-day Code-a-Thon to use data and technology to develop new solutions to address the opioid epidemic.

In GAO Report, More Concern over VA VistA Modernization Project

A recent Government Accountability Office (GAO) report is calling into question the more than $1 billion that has been spent to modernize the Department of Veterans Affairs' (VA) health IT system.

Lawmakers Introduce Legislation Aimed at Improving Medicare ACO Program

U.S. Representatives Peter Welch (D-VT) and Rep. Diane Black (R-TN) have introduced H.R. 4580, the ACO Improvement Act of 2017 that makes changes to the Medicare accountable care organization (ACO) program.