There needs to be appropriate, risk-based oversight for health IT, and we hope the HHS report will recommend such a framework. Health IT has tremendous potential to improve patient care and lower health care costs, but we can only achieve these goals well with a new regulatory framework, crafted by Congress and signed by the president, that is modern and flexible enough for tomorrow’s technologies.
First, Congress must ensure current regulatory overlap and duplication is streamlined by creating a gatekeeper to farm technologies to the most appropriate regulator. Congress should update the definition of a Medical Device to reflect the evolving nature of medical technologies by differentiating between those that manage health information and those used to diagnose and treat patients. Second, technologies should be regulated based on their functionality and risk, with lower risk apps sent to contracted software experts who can judge whether the software does what it claims to do. Third, we must ensure approved apps are tracked post-approval for errors they may cause. Congress should create a collaborative mechanism for robust post-market surveillance that incentivizes safety and addresses adverse events quickly with a mix of punitive and non-punitive enforcement options.
Regulations as they stand were appropriate for 1970s America, but unfortunately cannot keep up with the pace of today’s innovations that are increasingly integrated into consumers’ daily lives. Congress must act to protect patient safety in a way regulators with their current tools cannot adequately do.
Joel White is the Executive Director of the Health IT Now Coalition.