Senate Bill Exempts Low-Risk Medical Software, Apps from Regulation
Senators Michael Bennett (D-Colo.) and Orrin Hatch (R-Utah) on Thursday introduced a bill to limit Food and Drug Administration regulation of health information technology products.
Senators Michael Bennett (D-Colo.) and Orrin Hatch (R-Utah) on Thursday introduced a bill to limit Food and Drug Administration regulation of health information technology products.
The bill is similar to legislation introduced in the House in October 2013, called the SOFTWARE Act and sponsored by Rep. Marsha Blackburn (R-Tenn.). Blackburn on December 3 said she is tweaking her bill to reflect changes suggested by stakeholders and the FDA, and expects to reintroduce it in January.
But introduction of the Senate bill in a lame-duck session of Congress suggests there is a move to pass such legislation before the 113th Congress adjourns on January 3. If that happens, the bill, with a simple amendment added, could also serve as the vehicle that physicians are seeking to delay the ICD-10 compliance date until October 2017.
The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act seeks to amend the definition of medical devices under the Federal Food, Drug and Cosmetic Act, exempting low-risk medical software and mobile apps from FDA regulation and providing “greater certainty regarding what software will be regulated by the agency to protect consumers,” according to a statement from the senators.
The bipartisan bill attempts to limit and clarify the FDA’s role regarding the regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records, and decision support software.
Industry groups and health IT vendors wasted no time in voicing their support for the MEDTECH Act. The Health IT Now Coalition said it applauded the bipartisan effort to update a 1970s law—the Federal Food, Drug and Cosmetic Act—defining what constitutes a medical device.
“It is time for our laws to reflect the technological advancements made in our healthcare system over the past four decades,” said Joel White, executive director of the Health IT Now Coalition, in a written statement. “It is unacceptable that the laws currently governing health software, mobile apps and devices like cell phones and tablets were designed and passed when ABBA was popular and the Watergate scandal was just unfolding. The regulatory framework in place is ill-equipped to adapt to today’s advanced technologies and patients are losing out.”
Joe Ganley, vice president of federal government affairs for McKesson, the world’s largest health IT vendor, sent a Dec. 4 letter to Bennet and Hatch thanking them for introducing the MEDTECH Act and voicing his company’s support for the proposed legislation.
“The MEDTECH Act seeks to provide critical clarity regarding the regulation of health IT,” wrote Ganley. “As you are aware, the Food and Drug Administration regulates all health IT under the broader category of ‘medical devices,’ a term that was statutorily defined in the 1970s. The MEDTECH Act clearly defines the categories of health IT and focuses FDA regulation on the technologies that pose the greatest potential risk. The legislation will promote patient safety while continuing to foster much needed innovation in healthcare.”
The bill is similar to legislation introduced in the House in October 2013, called the SOFTWARE Act and sponsored by Rep. Marsha Blackburn (R-Tenn.). Blackburn on December 3 said she is tweaking her bill to reflect changes suggested by stakeholders and the FDA, and expects to reintroduce it in January.
But introduction of the Senate bill in a lame-duck session of Congress suggests there is a move to pass such legislation before the 113th Congress adjourns on January 3. If that happens, the bill, with a simple amendment added, could also serve as the vehicle that physicians are seeking to delay the ICD-10 compliance date until October 2017.
The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act seeks to amend the definition of medical devices under the Federal Food, Drug and Cosmetic Act, exempting low-risk medical software and mobile apps from FDA regulation and providing “greater certainty regarding what software will be regulated by the agency to protect consumers,” according to a statement from the senators.
The bipartisan bill attempts to limit and clarify the FDA’s role regarding the regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records, and decision support software.
Industry groups and health IT vendors wasted no time in voicing their support for the MEDTECH Act. The Health IT Now Coalition said it applauded the bipartisan effort to update a 1970s law—the Federal Food, Drug and Cosmetic Act—defining what constitutes a medical device.
“It is time for our laws to reflect the technological advancements made in our healthcare system over the past four decades,” said Joel White, executive director of the Health IT Now Coalition, in a written statement. “It is unacceptable that the laws currently governing health software, mobile apps and devices like cell phones and tablets were designed and passed when ABBA was popular and the Watergate scandal was just unfolding. The regulatory framework in place is ill-equipped to adapt to today’s advanced technologies and patients are losing out.”
Joe Ganley, vice president of federal government affairs for McKesson, the world’s largest health IT vendor, sent a Dec. 4 letter to Bennet and Hatch thanking them for introducing the MEDTECH Act and voicing his company’s support for the proposed legislation.
“The MEDTECH Act seeks to provide critical clarity regarding the regulation of health IT,” wrote Ganley. “As you are aware, the Food and Drug Administration regulates all health IT under the broader category of ‘medical devices,’ a term that was statutorily defined in the 1970s. The MEDTECH Act clearly defines the categories of health IT and focuses FDA regulation on the technologies that pose the greatest potential risk. The legislation will promote patient safety while continuing to foster much needed innovation in healthcare.”
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