On April 3, the Food and Drug Administration (FDA), the Federal Communications Commission (FCC), and the Office of the National Coordinator for Health Information Technology (ONC) jointly issued a report that sets forth a proposed strategy and recommendations for a risk-based regulatory framework for health information technology (health IT). The report, which was mandated by Congress in the Food and Drug Administration Safety and Innovation Act (FDASIA), proposes that no new or additional regulations are needed to implement this regulatory framework. Instead, the three federal agencies propose a limited approach that “relies on ONC-coordinated activities and private sector capabilities.” In addition, the report proposes a mostly deregulatory approach for clinical decision support (CDS) technologies and states that the majority of these products would be considered to have “health management health IT functions,” which FDA does not intend to actively regulate. The precise scope of this deregulatory approach, however, has not yet been determined, and the agencies have requested input from the public on which types of CDS technologies should be considered health management health IT and which should be subject to FDA oversight.
Overview of the Report Recommendations: Limited Regulatory Oversight Proposed
The FDASIA provision requiring this report was triggered by concern among external stakeholders that health IT would be subject to overregulation because of the overlapping jurisdictions of FDA, FCC, and ONC in this area and the potential for duplicative regulation. In particular, stakeholders were concerned that overregulation would stifle innovation and investment in health IT, which has the potential to provide significant benefits in reducing medical errors and improving the quality and efficiency of healthcare delivery. Recognizing these concerns, the three agencies emphasized in the report the use of voluntary standards, best practices, and industry testing to mitigate patient-safety risks for the majority of health IT products. The report also recommends limiting active FDA oversight to those products with “medical device health IT functions.”
The strategy proposed by the three agencies would categorize health IT products into one of three buckets based on the functionality of the product: (1) administrative health IT functions; (2) health management health IT functions; and (3) medical device health IT functions. The first category includes functions such as billing, claims processing, practice and inventory management, general purpose communications, and scheduling. Because these activities pose limited or no risk to patient safety, the agencies proposed no additional regulatory oversight.
The second category, health management health IT functions, includes health information and data management, data capture and encounter documentation, electronic access to clinical results, medication management (electronic medication administration records), electronic communication and coordination, provider order entry, knowledge management, patient identification and management, and “most clinical decision support.” The bulk of the report’s recommendations focus on this category of health IT and include a myriad of proposals to help promote health IT safety and quality, including the promotion of quality management principles, the development and adoption of standards and best practices, the leveraging of conformity assessment tools (e.g., product testing, certification, and accreditation), and the creation of a new public-private Health IT Safety Center, which would “focus on activities that promote health IT as an integral part of patient safety with the ultimate goal of assisting in the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts.”
The report further states that FDA does not intend to focus its regulatory oversight on products with health management health IT functions, given their relatively low risk and the favorable risk-benefit profile, even if a health management health IT product met the statutory definition of a “device” under the Federal Food, Drug, and Cosmetic Act (FDCA).
The last category is health IT with medical device functionality. The report states that this category of health IT is and will continue to be subject to FDA’s oversight because these health IT products pose greater risks to patient safety and FDA oversight is better suited to ensure their safety and effectiveness. The report is unclear, however, on exactly where the agencies have drawn the line between heath management health IT and heath IT with medical device functionality. For example, the term “medical device functionality” is not explicitly defined; rather, the report simply references in a footnote the definition of a “device” under the FDCA. This reference is ambiguous, however, because the report also states that health management health IT will not be subject to FDA oversight even if it meets the definition of a device under the FDCA. Thus, it is not clear how to differentiate health IT with medical device functionality (which is subject to FDA regulation) from health management health IT that meets the definition of device under the FDCA (which is not subject to FDA regulation).
Agencies Seek Input for Open Question on CDS Technologies
Although the agencies have stated that “most” CDS technologies would be considered health management health IT, they also acknowledge that some of these are and will continue to be regulated as devices by FDA. The report provides only limited examples of CDS technologies currently regulated by FDA, including computer-aided detection and diagnostic software, software used to remotely display alarms from bedside monitors, radiation treatment planning software, robotic surgical planning and controls, and electrocardiography analytical software. Even with these limited examples, however, the report is not always consistent. For example, although the report indicates that computer-aided diagnostic software is FDA-regulated, it also states that software that provides “[s]uggestions for possible diagnoses based on patient-specific information retrieved from a patient’s [electronic health records]” would not be FDA-regulated. The latter statement is also inconsistent with FDA’s Mobile Medical Applications guidance, which states that software applications that “perform patient-specific analysis and provid[e] patient-specific diagnosis, or treatment recommendations,” are FDA-regulated.
The report also offers a different definition of CDS software than has been provided in prior FDA guidance. FDA previously defined CDS software as “stand-alone software (mobile or traditional workstation) that analyzes, processes, or interprets medical device data (collected electronically or through manual entry of the device data) for purposes of automatically assessing patient specific data or for providing support in making clinical decisions.” In this report, the agencies have proposed a somewhat vaguer definition, including health IT that “provides health care providers and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.”
Perhaps in recognition of the questions and ambiguities surrounding CDS technologies, the three agencies have requested feedback from the public on which types of CDS functionality should be considered health management health IT and which types should be subject to FDA oversight.
The report responds to the concerns expressed by the health IT industry regarding potential overregulation because of the overlapping jurisdictions of three federal agencies by establishing the roles of each agency in a risk-based regulatory framework. Although the proposed strategy suggests that FDA will not actively regulate technologies that fall within two of the three identified categories, there remains significant uncertainty regarding how FDA will determine whether CDS software is healthcare health IT software that is not directly regulated or whether it is medical device health IT that is actively regulated. Early indications are that FDA has determined to address these issues on a case-by-case basis.
FDA, FCC, and ONC are requesting feedback on the report and have established a docket for the submission of comments. Comments may be submitted until July 7, 2014.
If you have any questions or would like more information on the issues discussed in this update, please contact any of the following Morgan Lewis lawyers:
Michele L. Buenafe
. Id. at 4.
. Id. at 12, n. 36.
. Id. at 27.
. Id. at 26.
. FDA, Mobile Medical Applications, Guidance for Industry and Food and Drug Administration Staff, at 15 (Sept. 25, 2013).
. FDA, Availability of Draft Guidance for Mobile Medical Applications, 76 Fed. Reg. 43689, 43690 (July 21, 2011) (requesting comments on the regulation of stand-alone clinical decision support software).
. FDASIA Health IT Report, supra note 1, at 26.
. 79 Fed. Reg. 19100 (Apr. 7, 2014).