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Possibility of FDA Regulation of Health Information Technology Looms Large

P&T Journal
October 2013 - for a PDF copy of the published version go HERE.

Pharmacies and Their Vendors Worry About Quality

The hospital drive to implement health information technology (HIT) systems, driven in good part by Medicare and Medicaid incentives (and penalties), has certainly affected pharmacy systems, and will continue to do so as the definition of "meaningful use" is expanded to incorporate more required medication tasks. So anyone who works in a hospital pharmacy ought to be interested in how the federal government regulates these new technologies, be they hardware or software. Retail pharmacies, too, even though they are not being pressured by incentives, are concerned about how any regulation would affect mobile medical devices such as glucose monitoring/diabetes management, at home hypertension monitoring/management, medication management, and medication reconciliation at transitions of care. 

Pharmacy organizations such as the Pharmacy e-HIT Collaborative are communicating with a work group within the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) which will be making HIT recommendations to Congress imminently. That report will provide directions to the Food and Drug Administration (FDA).

Surescripts, too, is concerned about the failure of some pharmacy systems vendors to police the quality of their products. Surescripts provides the e-prescribing electronic backbone which software vendors plug into. Those vendors sell plugged-in e-prescribing systems directly to end-user pharmacies. David Yakimischak, General Manager, E-Prescribing, says the company has worked hard to encourage its vendors to adopt quality programs leading to fewer pharmacy errors. "Vendor responsiveness has been relatively random," he explains. "Quality/patient safety performance does not appear to play heavily in end-users’ purchasing decisions. Our conclusion is that in the absence of new incentives and penalties, there is currently little or no business case for vendors to make significant investments in high quality patient safety programs."

The FDA is under a congressionally-mandated deadline of January 2014 to produce a regulatory framework for HIT. The key issue is whether the FDA should be allowed to regulate all HIT as it does medical devices. Or should some HIT, especially software where pharmacists and physicians interact with a system to make clinical decisions or observations, even be regulated at all. There are those who think systems requiring clinical intervention should be certified, not regulated, by a non-federal body such as The Joint Commission, with that certification process overseen by the ONC. The ONC already has a few years of experience certifying HIT eligible for incentives (which go to the purchasers, such as hospitals) decreed by the 2009 stimulus bill. "The ONC is well positioned to coordinate oversight among these various organizations to ensure patient safety, prevent overlap and continue to foster innovation and adoption of health IT by providers," states Ann Richardson Berkey, Senior Vice President, Public Affairs, McKesson Corp. She says organizations such as the National Committee for Quality Assurance (NCQA), The Joint Commission or URAC have track records in the rigorous accreditation of healthcare software.

The American Hospital Association (AHA) thinks products should be regulated based on the risk they pose to patients. Key factors to be considered include the potential for harm, the extent of harm, and the extent to which software is automating and or guiding clinical decision-making. "For example, when drug dosage data are sent from an order entry system to a pharmacy information system, it is crucial for safety that both the data points and their units of measure are accurate within each system and across systems," says Linda E. Fishman, Senior Vice President, Public Policy Analysis & Development, AHA.

Last February, the Bipartisan Policy Center, a think tank of sorts meant to meld Democratic and Republican views, produced a report called An Oversight Framework for Assuring Patient Safety in Health Information Technology. It stated: "The FDA’s current regulatory approach for medical devices is generally not well-suited for health IT." The report recommends that HIT products be divided into three categories according to the relative risk to patients and the opportunity for clinical intervention. Those where there is no or little opportunity for clinical intervention represent a higher potential risk of patient harm. Such devices are currently regulated by the FDA as Class I, Class II, or Class III medical devices. The FDA would continue to regulate these devices.

The lowest risk category would be administrative software which supports the administrative and operational aspects of healthcare but is not used in direct delivery of clinical care. Population analytics, back office billing systems, claims payment systems, and prescription drug refill reminders are all examples of software that are not used for patient specific treatment or diagnosis. The BPC recommends no additional oversight for this category.

The middle category would include products which can be used to recommend a course of care; call this category clinical software. Very few participants in the debate, at least on the industry side, think this category should be regulated by a federal agency.
Meanwhile, the ONC's ability to translate its considerable HIT experience into political weight in any upcoming battle with the FDA over new regulations is compromised by the absence of a National Coordinator, given the departure of Farzad Mostashari, M.D. The position needs to be filled quickly, and for a lot of reasons.