In the JournalsPerspective

Experts express concerns about FDA precertification program for health apps

In a new commentary published in Annals of Internal Medicine, experts suggest that the FDA’s Digital Health Software Precertification Program may lead to less rigorous FDA oversight and studies of safety and effectiveness of marketed digital health apps, with uncertain patient outcomes.

“The [FDA’s] Digital Health Software Precertification (Pre-Cert) Program is designed to expedite regulatory review for companies that demonstrate quality and organizational excellence in software development,” Theodore T. Lee, BA, from Yale University, and Aaron S. Kesselheim, MD, JD, MPH, from Brigham and Women’s Hospital and Harvard Medical School, wrote. “Although Pre-Cert is intended to promote the worthy goals of access and innovation in digital health, many questions have been raised.”

In their commentary, Lee and Kesselheim assess the benefits and risk of the Pre-Cert program and the debates on regulating health-related software as a medical device.

Apple, Samsung, Verily, Johnson & Johnson, Roche, Fitbit, Pear Therapeutics, Phosphorus and Tidepool were chosen to participate in the Pre-Cert pilot program. The nine companies were required to share quality management information with the FDA, collect and report postmarket data and allow visitation from the FDA, according to the authors.

Lee and Kesselheim note that instead of medical devices, Pre-Cert focused on free-standing software, mainly apps designed to diagnose or treat disease.

There is concern that developers may not be appropriately incentivized under the Pre-Cert program to review software products regarding safety and efficacy before patients access them, according to Lee and Kesselheim. Many patients and physicians may believe that marketed products have been rigorously evaluated; therefore, the program may also cause confusion, they wrote.

Regulatory flexibility is necessary because the apps could be frequently updated, they wrote.

“Given limited resources, the FDA cannot review every health app undergoing constant iterations,” Lee and Kesselheim concluded. “However, for medical software devices that purport to diagnose or treat disease, adequate study of safety and effectiveness is needed at some point in their lifecycle regardless of developers’ internal quality processes. Without that, the Pre-Cert approach will ascribe FDA validation to more new products that have not established actual clinical benefits.” – by Alaina Tedesco

Disclosure: Lee reports consulting for Bain & Company. Kesselheim reports receiving grants from Laura and John Arnold Foundation, Harvard Program in Therapeutic Science and Engelberg Foundation.

In a new commentary published in Annals of Internal Medicine, experts suggest that the FDA’s Digital Health Software Precertification Program may lead to less rigorous FDA oversight and studies of safety and effectiveness of marketed digital health apps, with uncertain patient outcomes.

“The [FDA’s] Digital Health Software Precertification (Pre-Cert) Program is designed to expedite regulatory review for companies that demonstrate quality and organizational excellence in software development,” Theodore T. Lee, BA, from Yale University, and Aaron S. Kesselheim, MD, JD, MPH, from Brigham and Women’s Hospital and Harvard Medical School, wrote. “Although Pre-Cert is intended to promote the worthy goals of access and innovation in digital health, many questions have been raised.”

In their commentary, Lee and Kesselheim assess the benefits and risk of the Pre-Cert program and the debates on regulating health-related software as a medical device.

Apple, Samsung, Verily, Johnson & Johnson, Roche, Fitbit, Pear Therapeutics, Phosphorus and Tidepool were chosen to participate in the Pre-Cert pilot program. The nine companies were required to share quality management information with the FDA, collect and report postmarket data and allow visitation from the FDA, according to the authors.

Lee and Kesselheim note that instead of medical devices, Pre-Cert focused on free-standing software, mainly apps designed to diagnose or treat disease.

There is concern that developers may not be appropriately incentivized under the Pre-Cert program to review software products regarding safety and efficacy before patients access them, according to Lee and Kesselheim. Many patients and physicians may believe that marketed products have been rigorously evaluated; therefore, the program may also cause confusion, they wrote.

Regulatory flexibility is necessary because the apps could be frequently updated, they wrote.

“Given limited resources, the FDA cannot review every health app undergoing constant iterations,” Lee and Kesselheim concluded. “However, for medical software devices that purport to diagnose or treat disease, adequate study of safety and effectiveness is needed at some point in their lifecycle regardless of developers’ internal quality processes. Without that, the Pre-Cert approach will ascribe FDA validation to more new products that have not established actual clinical benefits.” – by Alaina Tedesco

Disclosure: Lee reports consulting for Bain & Company. Kesselheim reports receiving grants from Laura and John Arnold Foundation, Harvard Program in Therapeutic Science and Engelberg Foundation.

    Perspective

    Matthew Faiman

    In the commentary in Annals of Internal Medicine by Lee and Kesselheim regarding the new FDA Pre-Cert program, numerous observations and concerns have been raised. As a practicing Internist and Virtualist (telehealth provider), I am keenly aware of the balance of getting new technologies into the hands of our patients. Recognizing that our smartphones are becoming ever smarter has become a unique challenge for clinicians, especially as we integrate clinical care with new medical apps.

    With its permissive approach to software developers, the new Pre-Cert program is somewhat ambiguous in how it is applying the overarching concept of what defines a medical device. As such, the transformation of a smartphone into a diagnostic tool may be a large leap for the medical community if not vetted appropriately.

    As the American Psychiatric Association has suggested, there may be some ways to mitigate the concerns. Ensuring the privacy of the data (and thus the patient), evaluating the strength of evidence behind the app itself, and making sure the app is easy to use and is interoperable (with the EMR for example) are excellent starting points.

    Patients rely on recommendations from their health care providers for apps and devices. But in many instances, they seek them on their own. If they see that an app or device is approved by the FDA’s Pre-Cert program, there may be a tacit assumption that the health product is safe and effective, and it may not be.

    Lee and Kesselheim reference numerous instances that are cause for concern. Before we move this process forward, we should make sure there is sufficient clinical evidence that these apps and devices are effective beyond their technical programming. In our organization, we are piloting many of these apps into clinical situations and scenarios to show that efficacy, safety and privacy concerns are being met. This should be a minimum standard in my opinion.

    • Matthew Faiman, MD, MBA
    • Medical Director
      Cleveland Clinic Express Care Online

    Disclosures: Faiman reports no relevant financial disclosures.

    Perspective

    Seth Martin

    This is a nice perspective by Lee and Kesselheim on the FDA precertification program for digital health software. With rapid innovation occurring in the digital health space, the FDA has developed a company-focused rather than product-focused approach to expedite regulatory review.

    The FDA simply cannot review every health app. The administration is trying to encourage the disruption happening in health care while providing reasonable oversight. It is a balancing act.

    My take away is that the FDA is being open minded and creative. I am impressed how they have worked with the initial cohort of nine companies and are rapidly trying to integrate what they are learning. Yet, when it comes to validating the products themselves and their clinical value, we in academic medicine are best positioned to lead the charge.

    • Seth Martin, MD, MHS
    • Assistant Professor of Medicine
      Johns Hopkins University

    Disclosures: Martin reports receiving research funding from Apple, Google and Nokia.