Person selecting health on their computer keyboard When President Obama signed the Patient Protection and Affordable Care Act (ACA) into law in 2010, one of its core tenets was expanding use and access to health technology, both by health care providers and consumers. The ACA passed at a time when the health software, app development, and mobile device industries were poised for exponential growth. In 2010, only about 20 percent of smartphone users used their device to research health information, and the number of health apps on the market was fewer than 15,000. By December 2014, health and fitness apps were the fastest growing category, and more than 100,000 mobile health apps were available. According to PricewaterhouseCoopers, one in five Americans owns a wearable health and fitness device, such as a Fitbit, and one in 10 wears the device daily. Plus, two in three health care providers are using a smartphone or tablet in the daily patient care routine. A question remains, however: How will health technology be regulated?

FDA and Health Technology

FDA Makes Moves to Advance Digital Health | Health Law Advisor n 1976, the FDA issued its first guidelines, covering what the organization considered health technology at the time. Any “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory…” would need FDA approval before consumer use. In 1976, leading health technology included items such as contact lenses and cochlear implants. Early regulators could not anticipate the health technology commonly used today. Over the past few years, new fields such as health informatics have contributed to developments in advanced devices, home and personal health sensors and telehealth technology, that are transforming health care. Despite these advances, the FDA continues to approve and regulate these technologies using guidelines developed during the Jimmy Carter era.

Congress, Health Technology, and the FDA

As the health technology market continued to grow, the FDA indicated to developers and CEOs that the agency would take a light approach to regulating health care apps and wearables. However, the lack of written guidelines stifled development; companies were hesitant to undertake developing new technology that would later be subject to oppressive regulations and no longer eligible for direct marketing to consumers. In 2014, Sen. Orrin Hatch introduced the MedTech Act, exempting electronic health records and other consumer health software from FDA regulation. Rep. Marsha Blackburn followed suit with the SOFTWARE Act (Sensible Oversight for Technology which Advances Regulatory Efficiency), further clarifying the FDA’s role in consumer health technology products. Finally, early in 2015, the FDA responded to growing calls for concrete guidance on handling consumer health technology and wearable devices. In a release met favorably by health care CEOs and CMOs, the FDA indicated it would not regulate any device that did not pose a serious health risk to the consumer if the device malfunctioned. The FDA also stated it would not regulate apps providing fitness tracking or tracking and recording of basic health metrics. With these new guidelines in place, the stage is set for further innovation and development in health care wearables and apps. The FDA has also positioned itself to streamline approval of regulated devices, giving consumers more tools to monitor and manage their health.