Last month, Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) introduced proposed legislation, the PROTECT Act (Preventing Regulatory Overreach To Enhance Care Technology) of 2014 (full text available here), which seeks to remove the Food and Drug Administration’s (“FDA”) regulatory authority over certain health information technology (“health IT”) software.
Main Provisions of the PROTECT Act
Specifically, the bill proposes that “clinical software” and “health software” shall not be subject to regulation under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). The bill defines “clinical software” as “clinical decision support software or other software (including any associated hardware and process dependencies)…that captures, analyzes, changes, or presents patient or population clinical data or information and may recommend courses of clinical action…and is intended to be marketed for use only by a health care provider in a health care setting.”
The term “health software” means “software (including any associated hardware and process dependencies) that is not clinical software and (a) that captures, analyzes, changes, or presents patient or population clinical data or information; (b) that supports administrative or operational aspects of health care and is not used in the direct delivery of patient care; or (c) whose primary purpose is to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data.”
Both “clinical software” and “health software” would not include software “(a) that is intended to interpret patient-specific device data and directly diagnose a patient or user without the intervention of a health care provider; (b) that conducts analysis of radiological or imaging data in order to provide patient-specific diagnostic and treatment advice to a health care provider; (c) whose primary purpose is integral to the function of a drug or device; or (d) that is a component of a device.”
The PROTECT Act also proposes that the National Institute of Standards and Technology (“NIST”) be the Federal agency that oversees technical standards used by clinical software. In addition, the Act recommends that NIST, along with the Federal Communications Commission, the National Patient Safety Foundation, and the Office of the National Coordinator for Health Information Technology, collaborate with nongovernmental entities to develop certification processes and promote best practice standards for health IT.
PROTECT Act Supporters Cite FDA’s Overreach and Slow Process
Proponents of the bill argue that, given the FDA’s broad definition of “medical device”, the FDA’s authority to regulate health IT is too extensive and that the FDA’s slow safety review process hurts innovation. Senator King explained to the Boston Globe, “While blood-glucose monitors, pacemakers, and other high-risk devices must remain under the current FDA regulations, low-risk software like wellness apps and electronic health records need not be subject to burdensome regulations.”
Although the FDA in September 2013 issued non-binding guidance on how the agency would regulate mobile medical applications, some in the health IT industry are uncomfortable with the uncertainty surrounding the FDA’s regulatory discretion. Along with athenahealth, which issued a document called “In Defense of the PROTECT Act,” supporters of the bill include IBM, Verizon, McKesson, and Software & Information Industry Association.
Critics Raise Patient Safety Concerns
Critics contend that the PROTECT Act’s creation of a regulatory exception for health IT software undermines the FDA’s role in safeguarding the public’s health. They warn that flaws with digital records systems can lead to dangerous, and even fatal, consequences. A 2011 Institute of Medicine report found that “dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human-computer interactions or loss of data have led to serious injury and death.” A more recent study of medical malpractice claims confirms that electronic health record-related vulnerabilities such as faulty data entry, unexpected conversions, or incorrect files/fields can lead to medical errors.
PROTECT Act opponents argue that patient safety is an area that the FDA has experience with and should regulate, whereas NIST’s mission is to promote U.S. innovation and industrial competitiveness. The mHealth Regulatory Coalition, along with other advocacy groups like the National Physicians Alliance, Public Citizen, and the Union of Concerned Scientists have voiced concerns about the PROTECT Act.
Those interested in the future policy and regulatory framework of health IT should keep an eye on this proposed legislation. In the coming months, the Obama administration also plans to release recommendation on how health IT systems should be regulated for safety. As the adoption of health IT and electronic health records systems expands and as health IT becomes more sophisticated, the proper role of the FDA in regulating the safety of health IT will continue to be a subject of intense debate.