ONC Issues Recommendations for FDA's Mobile Health Regulation Framework

Posted 05 September 2013 | By

The US government's Health Information Technology (HIT) Committee of the Office of the National Coordinator (ONC) has called on the US Food and Drug Administration (FDA) to work within its current regulatory frameworks to help spur the innovation of mobile health technologies, rejecting calls for an overhaul of current regulations.


The ONC's HIT has for months been working to generate a proposal regarding the future of mobile health technologies, which are notably regulated by not one but three federal entities: FDA, ONC and the US Federal Communication Commission (FCC).

The overarching goal is to simplify this regulatory paradigm such that companies understand which agency's requirements they will be expected to meet and how they can expect to meet them when they want to bring a new product to market.

ONC's report was specifically called for by the 2012 FDA Safety and Innovation Act, which called for a report to "offer a proposed strategy and recommendations for an appropriate risk-based Health IT regulatory framework that would include mobile medical applications and promotes innovation, protects patient safety, and avoids regulatory duplication."

To facilitate the development of that report, FDA has been working with ONC and FCC in the form of a new group called the FDASIA Workgroup to assist ONC's Health Information Technology (HIT) Policy Committee to provide recommendations.

According to Federal Register notices, those recommendations are set to fall into three areas:

  1. types of risk that may be posed by health IT that impact patient safety, the likelihood that these risks will be realized, and the impact of these considerations on a risk-based approach
  2. factors or approaches that could be included in a risk-based regulatory approach for health IT that also promotes innovation and protect patient safety
  3. approaches to avoid duplicative or overlapping regulatory requirements

ONC Recommendations

Now the HIT Committee is out with many of its recommendations, giving a strong boost to FDA's current attempts to work within its current regulatory framework.

On 4 September 2013, the group released a set of its recommendations. One report by its regulations subgroup broadly covered three main points:

  1. FDA can use its current regulatory framework to "clarify ambiguities" by establishing clear policies for how it would exempt lowest-risk HIT products and most Class I medical devices, exempting most HIT from good manufacturing practice regulations under 21 CFR 820, expedite guidance on mobile medical applications and other HIT, and educate the public on requirements.
  2. Agencies-FDA, FCC and ONC in particular-should do their best to work together to delineate authority and eliminate duplicity. Review processes should, to the extent possible, be coordinated.
  3. New frameworks should be considered, particularly for adverse event reporting, data gathering and industry self-regulation. ONC said models like the National Highway Traffic Safety Administration and the Aviation Safety Reporting System might be useful for reporting adverse events to ensure more timely reporting and better safety and performance data.

Issues to Address

In addition, the ONC report says that FDA needs to address four "main" issues now facing mobile health technologies:

  • There is no clear distinction between general wellness and disease-related claims, particularly with respect to weight-related claims and obesity.
  • Because many mobile devices come with accessories, FDA needs to define levels of risk for these accessories and determine which are worth regulating and which are worthy of enforcement discretion.
  • Clinical support decision software needs to have a clear regulatory paradigm, as the agency "has never been clear on the contours of its regulation for this broad category of general health and medical software" despite many such devices being of low risk to patients.
  • Some software is modular, and is intended to be used with other products. ONC said FDA needs to determine which modules are devices and which are simply general modules able to be incorporated into health-related software.

Elsewhere in its report, the HIT Committee said FDA's device regulations could be improved to clarify the regulatory considerations that come into effect when medical software is used on general devices, such as smartphones. Last year, legislators publicly pressed FDA to state if it believed smartphones would be regulated by the agency if they ran medical device software. FDA rejected that it would, though it considered that problems could occur if the software and device did not work properly together.

ONC also said that the FDA regulatory process is not well defined or easy to understand, and that more public outreach would be useful in educating stakeholders, many of whom have no prior experience in the regulated healthcare products space.

What will be Regulated by FDA?

The report also includes a taxonomy section, which defines what is-and just as importantly, what isn't-a medical device with respect to HIT regulations.

Potentially Should be Regulated

Most Likely Shouldn't be Regulated

  • EHRs (installed and SaaS)

  • Hospital information systems-of-systems

  • Decision support algorithms

  • Visualization tools for anatomic, tissue images, medical imaging and waveforms

  • Health information exchange software

  • Electronic/robotic patient care assistants

  • Templating software tools for digital image surgical planning

  • Claims processing software

  • Health benefit eligibility software

  • Practice management / Scheduling / Inventory management software

  • General purpose communication applications (e.g., email, paging) used by health professionals

  • Software using historical claims data to predict future utilization/cost of care

  • Cost effectiveness analytic software

  • Electronic guideline distribution software

  • Disease registries

The full ONC recommendations are available on its website.


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