HITPC: Committee approves FDASIA workgroup draft recommendations

The Heath IT Policy Committee approved a slew of draft recommendations presented by the FDA Safety and Innovation Act (FDASIA) Workgroup at its meeting on Sept. 4.

The workgroup’s recommendations ultimately will inform the FDA, Office of the National Coordinator for Health IT and the Federal Communications Commission as they develop a strategy for a risk-based regulatory framework pertaining to health IT that promotes innovation, protects patient safety and avoids regulatory duplication. Per the legislation, the proposed strategy is required by January 2014.

Workgroup Chair David Bates, MD, MSc, presented a 54-slide presentation on the workgroup’s findings, which served as a culmination of three months of deliberation, he said. The group was broken into three subgroups—taxonomy, risk/innovation and regulation—to investigate several aspects of a possible framework.

Bates cited several incidences where health IT compromised safety, including a case where the mortality rate increased from 2.8 to 6.3 percent in children transferred in for special care after introduction of a commercial CPOE application. “It is clear regulations can have adverse effects,” he said.

Bates said that the group determined that federal agencies should remove regulatory burdens as much as possible for low-risk technology while fine tuning their roles and responsibilities pertaining to higher-risk technologies.

To that end, the workgroup concluded that the definition of what is included in health IT should be broad but have also described exclusions, that the patient-safety risk framework and examples should be used as building blocks to develop a transparent framework and that federal agencies need to address deficiencies, ambiguities and duplication in their oversight. The framework should preserve the ability for the industry to innovate.

Overall, the workgroup put forth the following recommendations:

• Health IT should not be subject to FDA premarket requirements, except when they constitute medical device accessories (to be defined clearly by FDA), they are certain forms of high-risk clinical decision support, such as computer-aided diagnostics (to be defined clearly by FDA) or when they are higher risk software cases
• Vendors should be required to list products which are considered to represent at least some risk if a non-burdensome approach can be identified to doing so
• A collaborative process with stakeholder participation is needed for health IT post-market surveillance
• Post-market surveillance of health IT should include user self-reporting and reporting from vendors and transparency and post-implementation testing to ensure key safety-related decision support is in place
• Approaches are needed to allow aggregation of safety issues at the national level, including federal support
• Cross-agency collaboration will be essential to determine regulatory boundaries
• This approach would be provisional, to be re-examined periodically

To view the entire presentation, go here and select “FDASIA Recommendations draft.”