Rep. Marsha Blackburn, R-Tenn., introduced a bill Wednesday...
Rep. Marsha Blackburn, R-Tenn., introduced a bill Wednesday to clarify regulations for healthcare-related software (http://1.usa.gov/1a7BHaE). The Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act would codify some of the Food and Drug Administration’s guidelines (http://1.usa.gov/140wCKv) on protecting medical…
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devices, which were updated this summer to include an expanded section on cybersecurity. The FDA “lacks the necessary tools to appropriately oversee” the rapidly growing amount of medical software “without overstepping their authority and stifling innovation,” said a news release from Blackburn. The agency could broadly define the term “medical device” to assert far-reaching control over new medical software. The bill aims to explicitly define exactly which types of software the FDA could closely oversee. “This bill would provide the FDA with the tools it needs to effectively protect consumers who use high risk technologies, while allowing the innovation of low risk technologies to continue without being caught up in the expensive and time consuming FDA approval process all while protecting patient safety,” Blackburn said in a statement.