Liveblog Day 2: Congressional hearing on FDA regulating apps

By Brian Dolan

10:44AM: Classen is largely extolling the success of health IT implementation and the reduction in medical errors. He's going deep into the way that health IT can lead to threats to patient safety. Very complex system problem he argues. Here's a snippet from his testimony that he just read: "Safety is an emergent property of a larger system that takes into account not just the software but also how it is used by clinicians. That larger system – often called a sociotechnical system – includes technology (e.g., software, hardware), people (e.g., clinicians, patients), processes (e.g., workflow), organization (e.g., capacity, decisions about how health IT is applied, incentives), and the external environment (e.g., regulations, public opinion). Adopting a sociotechnical perspective acknowledges that safety emerges from the interaction among these various factors."


10:42AM: Dr. Classen from Pascal Metrics is up next.

10:41AM: Mitus concludes with suggestion of three tier regulation from Bipartisan Policy Center:

The first category includes technology linked to or used to operate a medical device; again, technology that directly touches the patient. This technology would continue to be regulated by the FDA as a “medical device”.

The second category includes technology that informs the treatment of a patient, such as clinical decision support software or EHRs. This software would be subject to a rigorous process of accreditation by an independent third-party, or perhaps ONC.

Finally, the third category, non-clinical technology such as billing and scheduling software, would not be subject to any regulatory oversight.

This proposed framework recognizes the fundamental difference between traditional medical devices that are directly involved in the treatment of a patient, and medical software that helps guide the physician in the diagnosis or treatment of a patient.

10:38AM: Mitus says health IT does not replace physician judgement but provides support. FDA has authority to regulate medical devices thanks to an amendment of act from 1976. She says it is broad and not well suited to health IT. Does an iPad that reminds a patient to refill a medication make it a medical device? An app that lets physicians view medical literature online? Safety of medical device almost entirely rests on how it is manufactured. Safety of health IT is based on how it is implemented. Medical devices unlike health are directly involved in treatment of patient with little or any opportunity for clinician to intervene. Health IT provides data and guidance and has a learned intermediary that distinguishes it from medical devices.


10:37AM: McKesson's Dr. Mitus is up now. Making two key points today. Health IT is crucial to healthcare. And we need a new risk-based, specific regulatory framework that is specific to health IT.