The U.S. Senate Committee for Health, Education, Labor and Pensions, known as HELP, recently passed its marked version of the Medical Electronic Data Technology Enhancement for Consumers' Health Act, S. 1101, commonly known as the MedTech Act. Senators Michael Bennett and Orrin Hatch originally introduced the Act to high hopes late in 2014. A similar version of the legislation previously passed the House as part of the 21st Century Cures Act.

Industry and politicos alike are hungry for the relief and acclaim expected to accompany final passage. The Act is intended to provide comfort and stability at the dynamic intersection of medicine and technology by offering assurances that software designed for use in observational, monitoring, and lifestyle products will not be regulated by the U.S. Food and Drug Administration ("FDA").

By carving certain medical and decision support software out of the definition of "device," the Act limits FDA's regulatory authority with respect to software applications used for administrative functions, financial management, and static record review, as well as software designed to facilitate care coordination, data transfer, and development of treatment plans and recommendations. In doing so, the Act furthers industry and political aims of moving the FDA out of the way when it comes to low-risk, innovative software such as that used for wellness and lifestyle programs and similar applications. This is good news for commonly used wearables like wristbands and watches, and it presages brisk mainstreaming of related applications, such as in clothing, seating, steering wheels, earbuds, glasses, and contact lenses that monitor and report health, fitness, and wellness information.

While loosening the reins on applications seen as low risk, the legislation redirects FDA's focus to higher-risk medical software and devices, such as imaging, diagnostic, and implantable devices.

Be forewarned: What the Senate giveth, the FDA may taketh away, albeit via a public regulatory process. Under the Act as proposed, if the Secretary of Health and Human Services determines that an otherwise exempt software function would be "reasonably likely" to have "serious adverse health consequences," the Secretary may take action to enable the FDA to regulate the product or software as a medical device. In making such a finding, the FDA must consider matters such as the degree of harm likely to result if the software malfunctions, the extent to which the software is intended to support or influence clinical judgment, the opportunity for medical or professional intervention (such as review of the basis for treatment recommendations provided by the software), and the intended user and environment of use. Before taking action, the Secretary must publish its findings, including supporting evidence, in the Federal Register and offer a public comment period of at least 30 days. Only after the conclusion of that process may the Secretary regulate the software as a device.

Not everyone favorably views a more relaxed regulatory approach. Some fear that reliance on unregulated devices will lead to complacency. Others point to risks of manufacturing defects; susceptibility to bugs, glitches, viruses, and breaches; and possible lapses in the energy and connectivity infrastructure essential for these apps and devices to operate.

Ironically, the American Medical Informatics Association applauded the Act as necessary "to help ensure innovative products can more easily come to market" and at the same time called for "additional support from the federal government to tackle this mounting challenge" of ensuring health IT patient safety, concluding, "[n]ow is the time to fully fund a collaborative, national center for health IT safety."

While we live in a heavily regulated time, the pace of technological innovation in the health industry, as now fueled by consumer demand and a national health care framework dependent on big data and data analytics, is poised to accelerate, notwithstanding a few glitches along the way.

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