Out-Law News 2 min. read
25 Sep 2013, 5:45 pm
Technology law expert Allistair Booth of Pinsent Masons, the law firm behind Out-Law.com, said that the final guidance (43-page / 270KB PDF) was "consistent" with previous communications from the regulator; which indicated that it intended to take "a risk-based approach to the regulation of what is a very broad scope of m-health technologies".
The new guidance will predominantly apply to those applications, or 'apps', that present "a greater risk to patients if they do not work as intended", according to the FDA. These include apps that effectively turn a mobile device into a regulated medical device, for example by allowing a smartphone to detect abnormal heart rhythms; or apps that are intended to be used as an accessory to a regulated medical device.
"We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly," said Jeffrey Shuren, director of the FDA's Center for Devices for Radiological Health. "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products."
"Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly. The FDA's tailored policy protects patients while encouraging innovation," he said.
Mobile medical apps are software programs that run on mobile communication devices, such as smartphones and tablet computers, and perform the same functions as traditional medical devices. Functions range from calorie counters and pedometers that allow consumers to manage their own health and wellness, to allowing doctors to diagnose patients with potentially life-threatening conditions away from traditional health care settings.
These apps are becoming increasingly popular according to the FDA. Of the 100 mobile medical applications it has granted approval to over the past decade, around 40 of those have been approved in the last two years. The FDA has the power to regulate medical devices, along with food, drugs and cosmetics, under the US Federal Drug and Cosmetic Act (FDCA).
According to the guidance, the FDA recognises the "extensive variety" of apps available and the range of potential benefits and risks these apps could represent to public health. It therefore intends to distinguish between apps that pose a "lower risk" to the public, and a "subset" of apps "whose functionality could pose a risk to a patient's safety if the mobile app were to not function as intended". The FDA said that it would "exercise enforcement discretion" and not enforce the FDCA requirements in relation to low risk apps.
The FDA will instead concentrate on regulating apps that "can transform a mobile platform into a regulated medical device by using attachments, display screens, sensors or other such methods". Examples given include apps that allow mobile devices to be used to diagnose abnormal heart rhythms, work as a mobile ultrasound device or function as the 'central command' for a glucose meter used by a person with insulin-dependent diabetes. These apps will be assessed using the same regulatory standards and approach that the FDA applies to other medical devices, it said.
The FDA does not intend to regulate mobile devices themselves, or the 'app stores' that sell medical apps, it said.
Allistair Booth of Pinsent Masons said that the industry would be watching to see if other regulatory authorities followed the FDA's lead.
"Under the FDA's risk-based approach, apps that provide general generic health-related information will not be regulated whereas apps that are used as diagnostic tools and/or those that transmit crucial patient information will be," he said.
"The third 'middle ground' category, in which the FDA reserves its right to exercise enforcement discretion, is going to give rise to a degree of uncertainty for companies developing technologies that might be in that category," he said.
