The FDA continued to build on the digital health groundwork it laid last year, greenlighting new technologies and expanding a streamlined approval process for software vendors in 2018.
The FDA's digital health team has kept busy since agency officials unveiled plans for the unit in mid-2017. In fact, the team — mainly tasked with developing a new regulatory pathway to evaluate the safety of digital health products — has been seeking more clinicians, health scientists and software engineers to join the unit as advisers.
Here are three moves the FDA's digital health team made this year:
1. Greenlighting a wave of 'firsts' for digital health
The FDA cleared many novel digital products this year. In September, Apple COO Jeff Williams announced the newest Apple Watch would include an FDA-cleared electrocardiogram app. In August, the agency approved marketing of the first direct-to-consumer birth control app — a contraceptive method developed by Swedish company Natural Cycles Nordic AB.
Early in 2018, the FDA also approved IDx to market IDx-DR, a medical device that uses artificial intelligence to detect an eye disease called diabetic retinopathy. The approval was a landmark decision, representing the first FDA-authorized medical device to provide a screening decision without needing a specialist to interpret the results, opening the door for use by primary care physicians.
FDA Commissioner Scott Gottlieb, MD, has emphasized the potential for AI to improve early detection of various diseases, and in an April speech, said the agency would work with AI experts to develop a strategy to oversee these technologies. "We're actively developing a new regulatory framework to promote innovation in this space and support the use of AI-based technologies," he said at the time.
2. Building out its software precertification program
In one of the most notable regulatory moves of 2017, the FDA launched the Digital Health Software Precertification Program, a development program that aims to streamline the approval process for digital health products — such as AI devices — by reviewing developers, rather than individual products.
The underlying premise of the program, housed under the agency's new Center of Excellence on Digital Health, is that digital health products should be evaluated differently than traditional medical devices, since software is frequently updated. And while the program hasn't been without detractors — in October, Senate Democrats questioned whether the program posed a risk to public safety — the FDA has maintained plans to expand it in 2019.
In June, the FDA released the second draft of its pre-cert program, expanding it to encompass a broader set of medical technologies. The FDA said it plans to launch a large-scale pilot of the program in 2019, building on lessons learned during its initial pilot, which included participation from tech giants like Apple and Fitbit in late 2017.
3. Strengthening security for internet-connected medical devices
In late 2018, Dr. Gottlieb outlined steps the FDA is taking to strengthen its cybersecurity program for medical devices, including releasing updated premarket guidance on assessing cybersecurity vulnerabilities, signing an information-sharing agreement with the Department of Homeland Security and creating a dedicated cybersecurity unit within the FDA's Center of Excellence for Digital Health.
It was, arguably, a long time coming. In 2018 alone, the American Hospital Association penned a letter urging the FDA to bolster cybersecurity requirements for medical device manufacturers, and the HHS Office of Inspector General released a report concluding the FDA's policies don't sufficiently outline how the agency should respond after identifying a security vulnerability in a medical device.
To date, there aren't any known cases of hackers exploiting cybersecurity vulnerabilities in a medical device in use by a patient. However, researchers have warned about the potential of such attacks — and Dr. Gottlieb has said the agency is working to proactively address the concern. "As innovation in medical devices advances and more devices are connected to hospital networks or to other devices, ensuring that devices are adequately protected against cyber intrusions is paramount to protecting patients," Dr. Gottlieb said in October, when announcing the agency's partnership with Homeland Security.