REGULATORY SPONSORED ARTICLE
Sponsored article
FDA Efforts to Balance Health IT Innovation and Safety
The US FDA looks to adopt a flexible approach to mobile medical app and Health IT regulation that will both foster innovation and protect the public health. By M Elizabeth Bierman of Morgan Lewis & Bockius.
A
s smartphones and tablets have become more a part of everyday life, their use for health care applications has also become more common. Some have expressed concern that the development and use of health information technology (health IT) may have outpaced the US Food and Drug Administration’s (FDA) ability to regulate this product category. There are predictions that 500 million smartphone users worldwide will be using a healthcare application (app) by 2015. The uses of health IT cross all diagnostic and therapeutic categories. Apps that appear on app store websites include those that help physicians and patients monitor symptoms to help adjust the dosing of medications, the diagnosis of potentially cancerous moles, assess the disease risk of patients with pulmonary arterial hypertension, and enable physicians to remotely monitor labor and delivery patients. In addition, smartphones are being adapted with accessories to perform certain diagnostic functions. For example, through the addition of accessories, a smartphone can be used as a stethoscope, otoscope, diagnostic camera, or blood glucose-testing device. With these important advances in healthcare—many of which enable lay users to perform some level of self-diagnosis and physicians to diagnose and treat patients remotely—come new safety concerns. The FDA, however, has largely been in catch-up mode over the last several years with respect to regulation of health IT and has not evaluated the majority of the hundreds of health IT-related products that have flooded the market during this time period. As a result, the FDA and other federal agencies are now grappling with how to strike the right balance between promoting innovation and ensuring safety, for both products already on the market and new products in development.
Overview of Past FDA Regulation of Health IT
The term “health IT” can be broadly defined, but for purposes of this article, health IT means software-based products intended for medical uses and under FDA’s jurisdiction, including medical device data systems, mobile medical applications and clinical decision support software. While electronic health records (EHRs) also are commonly understood to be a subset of health IT, the FDA has stated that, at present, it does not intend to regulate EHRs and, thus, EHRs are not addressed in this article. Many of the products that fall within the category of health IT are considered “medical devices” regulated by the FDA. Under the Federal Food, Drug, and Cosmetic Act, a “device is an instrument, apparatus, implement , machine, . . . or other similar or related article, including any component, part, or accessory, which is— (1) recognized in the official National Formulary, or The United States Pharmacopeia . . . (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease . . . , or (3) intended to affect the structure or any function of the body of man,” provided that such product does not meet the statutory definition of a “drug.” While many health IT products fall within the scope of this statutory definition, FDA regulation in this area has been ambiguous, confusing, or absent. FDA first sought to regulate standalone software products that met the statutory definition of “device” in 1989 with issuance of its draft “FDA Policy for the Regulation of Software Products.” This guidance was withdrawn in 2005, but included principles that are relevant to current discussions on balancing innovation
and safety. Specifically, the draft policy outlined a risk-based approach, stating that expert—or knowledge-based systems, artificial intelligence, and other types of decision support systems that are intended to involve “competent human intervention” before any impact on human health occurs would be considered medical devices but would not be “actively regulated.” The phrase “competent human intervention before any impact on human health occurs” meant that there is time and opportunity for clinical judgment and experience to be used to check and interpret a system’s output before such output is used in the diagnosis or treatment of a patient. Products meeting this description would be considered medical devices but would be exempt from FDA regulatory requirements (i.e., registration, listing, premarket review, labeling, good manufacturing practices, and adverse event reporting). These principles were further refined in a software workshop held by the FDA in 1996. Between 1996 and 2008, the FDA did not initiate any rulemakings or issue any guidance specifically applicable to standalone software or health IT products. During this same time period, the marketplace saw the launch of personal digital assistants, the early smartphones, and the iTunes store, followed shortly by the iPhone and other advanced smartphones. All of these advances provided convenient platforms and a marketplace for mobile medical apps, triggering their rapid growth. This created increased pressure on the FDA to establish a regulatory framework. Given how far technology had advanced, from 2007 to 2008 the FDA decided to move iteratively, tackling first those systems that were easiest to regulate and the lowest risk to patients. In February 2008, the FDA issued a proposed rule
12
LMG LIFE SCIENCES 2013