On Wednesday, 4 September 2013, a working group tasked with making recommendations for optimal regulation of health information technology (HIT) delivered its final report to the Food and Drug Administration (FDA or the agency), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC). The final report recommends only very low level regulation for low-risk HIT products and requests that the FDA expedite the final guidance on medical mobile applications for smartphones and other mobile devices (medical mobile apps).1 FDA officials say that the agency is considering the recommendations and will work with other agencies to issue a report on overarching regulation of HIT by January 2014.2

The FDASIA Workgroup was formed by the three government agencies in response to the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which called on these agencies to propose a comprehensive, risk-based regulatory framework for HIT by January 2014.3 The FDA, along with the FCC and ONC, created the Workgroup to make recommendations that will guide development of the framework.

Key Recommendations

The final recommendations of the Workgroup suggest using a decision tree and defining characteristics to assign HIT products to one of two categories:

  1. Possibly Subject to Risk-Based Regulatory Framework – e.g., electronic health records, hospital information systems, software templates for surgical planning, decision support algorithms, etc.
  2. Likely Not Subject to Risk-Based Regulatory Framework – e.g., claims processing software, email applications used by health professionals, health benefit eligibility software, etc.

The report proposes a decision tree approach where the following question is asked: Is the intended use to inform or change decision making about initiating, discontinuing, modifying, or avoiding care interventions or personal health management? Any products for which the answer to the question would be in the affirmative would potentially be subject to the regulatory framework

With respect to FDA regulation of HIT, the Workgroup generally recommended that HIT should not be subject to FDA premarket requirements, except for medical device accessories, certain high-risk clinical decision support tools, and higher-risk software use cases. In addition, the report proposes a risk-based regulatory matrix where risk level is informed by a number of factors such as purpose and intended use of the software, severity and likelihood of possible injury, transparency of software operation, complexity, use as part of a broader system, and network connectivity issues. For example, transparent information only products would be much lower risk than automated decision making tools (e.g., “intelligent” IV pumps).

In addition, the report recommends that the agency:

  • establish a policy of enforcement discretion for lowest-risk HIT;
  • exempt lower-risk HIT from good manufacturing practices (GMP);
  • expedite final guidance on HIT software and mobile medical apps; and
  • proactively educate the public about how policies/regulation impact HIT and medical mobile apps.

Additionally, the group urged the FDA to address certain ambiguities in FDA regulation of software. Specifically, the Workgroup suggested the FDA more clearly define the scope of what constitutes an accessory to a medical device, and possibly downclassify certain generic, low-risk software products currently regulated as accessories. The group also asked the FDA to define the scope of regulation of clinical decision support software as well as software modules designed to be incorporated into larger programs. Finally, the group suggested that the FDA clarify the distinction between wellness claims and disease-related claims, noting that claims for a low-risk product currently may subject the product to unnecessary FDA regulation.

Conclusions

It remains unclear how the FDA and the other regulatory agencies will proceed in light of these recommendations, particularly with respect to the anticipated guidance on medical mobile apps. Whether the agency will move forward with issuing the final guidance document, in parallel with developing the overarching multi-agency framework for regulating HIT, remains to be seen. As always, Hogan Lovells will continue to update the industry on key developments in this regard.