In the wake of the HITECH Act, which encourages healthcare providers to use Electronic Health Records (EHR) through subsidies and reduced Medicare payments, patients may know that providers routinely store and transmit electronically their personal health-related information.  Patients with chronic diseases might, however, be surprised to learn that many aspects of their medical care, from the interpretation of lab results, to medication dosage calculations and treatment recommendations, are increasingly handled by software instead of clinicians.

Chronic Disease Management Software (CDMS), like CoagClinic by Standing Stone Inc. and UM-developed AviTracks by Avicenna Inc., either integrates with EHR or works in its place, guiding clinicians through each step of their workflow.  CDMS typically leads clinicians through patient enrollment, assigns medication dosages based on medical history and drug interactions, aids in scheduling lab tests and clinic visits, automatically alerts clinicians about problematic lab results and missed appointments, and recommends treatment based on standardized treatment protocols.  Thus, with CDMS, clinicians are outsourcing some of their most important functions like medication dosing, lab interpretation, and treatment decisions to software programmers.  Considering CDMS is often used in anticoagulation clinics, where patients take warfarin, a risky anti-clotting drug with many adverse interactions, also used as rat-poison, it might seem problematic that important dosage and lab-interpretation tasks are largely left to programmers.

So far the FDA, which has authority to regulate devices “intended for use in the . . . cure, mitigation, treatment, or prevention of disease,” 21 U.S.C. § 321(h), has declined to regulate CDMS or related Health IT.  This is somewhat inconsistent with its past statements on medical software.

In 2002 the FDA released unofficial guidelines for manufacturers whose medical devices incorporate software, in their General Principles of Software Validation.  This guidance document specifies how manufacturers can comply with 21 C.F.R. 820, which requires that software undergo validation, design reviews, and testing.  The FDA justifies these requirements for software by noting that 7.7% of all medical device recalls were due to software failures, and “the vast majority of software problems are traceable to errors made during the design and development process.”  They conclude that “software engineering needs an even greater level of managerial scrutiny and control than does hardware engineering.”

In the 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the FDA issued additional guidance, this time requiring premarket approval for devices incorporating software.  This guidance document outlines steps that a manufacturer must complete before the FDA will initially approve a device, including analysis of the device’s “level of concern,” hazard, design, and software verification and validation.  Despite arguably having jurisdiction by the plain language, The FDA does not require pre or post market approval of CDMS or EHR software, instead leaving governmental oversight in this area to the Office of the National Director for Health IT.

One potential explanation is that the FDA is backing off CDMS, and Health IT generally, due to the enormous potential for cost savings and thus lower provider fees.  CDMS significantly limits bad outcomes due to clinician errors, thereby improving patient outcomes and clinic efficiency, and reducing exposure to malpractice liability.  CDMS is somewhat unusual in its potential to lower healthcare prices.  Most new medical technology adds to the cost of healthcare, as patients demand the newest treatment technology and clinicians seek opportunities to charge higher fees.  Additionally, because of this industry’s youth, CDMS manufacturers, like UM’s Avicenna, are likely to be smaller than the typical medical device manufacturer.  Burdensome regulations may stifle development in this new dynamic market.  Perhaps the FDA has recognized that in order to capitalize on CDMS’s huge potential benefits on patient outcomes, which will slash provider’s costs and ultimately prices, they must hold off imposing extra costs into the manufacturing process, at least in the short term.

Written by: Daniel Seidman