Many people are taking advantage of technology to monitor their health and vital signs. But should you monitor your heart with a smartphone? Is this technology approved or regulated by the U.S. Food & Drug Administration? Entering the market in increasing numbers are heart-monitoring apps that are intended to be used as medical devices, which – unlike fitness trackers – must be approved by the FDA. Some are designed for home use, while others are for health care providers.

Digital health technology has revolutionized health care, empowering consumers to make better-informed decisions about their health. The U.S. Food & Drug Administration (FDA) is reevaluating its oversight of digital health technology. The FDA seeks to ensure patients’ timely access to high-quality, safe, and effective digital health products.

Digital health products provide consumers with new health-related options for the prevention of diseases and management of chronic conditions, outside of traditional care settings. Software and technologies assist in diagnosis, treatment options, storing and sharing health records, and managing workflow. With advances in analytics, medical software can help address public health crises, such as the opioid epidemic, by providing immediate information on nearby treatment options and emergency help.

Digital health technology participants have brought new innovation and manufacturing processes. The connectivity of digital health products continues to improve safety and effectiveness through modifications and updates, while in turn triggering the need to address issues related to cybersecurity and interoperability.

The FDA notes that because digital health technology can impact the health of millions of Americans, it is vital to ensure that these products are high-quality and that they perform as intended and expected. The FDA’s traditional approach to hardware-based medical devices was not designed for software products.

To evaluate a new approach toward software, the FDA has announced a new pilot program for software developers as part of its Digital Health Innovation Action Plan, which provides details and timelines for an integrated approach to digital health technology. The plan issues guidance to provide clarity on the medical software provisions of the 21st Century Cures Act.

The Software Precertification Pilot Program is a voluntary program through which the FDA will develop a tailored approach toward regulating digital health technology. Under the Digital Health Innovation Action Plan, the agency will first consider the software developer and/or digital health technology developer, rather than the product, as is typical for more traditional medical devices.

The goals of the program are to:

  • Enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion;
  • Ensure high quality medical product software throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organization excellence (CQOE); and
  • Be a program that learns and adapts and can adjust key elements and measure based on the effectiveness of the program.

The FDA is seeking participants for the voluntary Software Precertification Pilot Program beginning August 1, 2017. The program will select up to nine participants who best match the selection criteria. The pilot program will begin September 1, 2017.

Companies that may be eligible to participate in the voluntary pilot program must meet following criteria:

  1. The company must be developing or planning to develop a software product that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).
  2. The company has an existing track record in developing, testing, and maintaining software products demonstrating a culture of quality and organizational excellence measured and tracked by Key Performance Indicators (KPIs) or other similar measures.
  3. While participating in the pilot, the company must agree to:
    • Provide access to measures described in selection quality number 2, listed previously (KPIs or similar measures).
    • Collect real-world post-market performance data and provide it to FDA.
    • Be available for real-time consultations with FDA.
    • Be available for site visits from FDA officials.
    • Provide information about the firm’s quality management system.

Also addressing so-called telemedicine, the American Heart Association (AHA) recently released a policy statement evaluating its use in cardiovascular and stroke care, assessing the effectiveness of telehealth in advancing healthcare quality. The focus of these efforts is to promote telehealth models that ensure patient access to high-quality cardiovascular and stroke care whole protecting patient safety and privacy.