Articles by Mark McCarty

Cybersecurity data lock

FDA says hospital IT systems may be hostile cybersecurity environments

Nov. 8, 2023
By Mark McCarty
As reported ipreviously in coverage by BioWorld, the U.S. FDA’s latest guidance on cybersecurity elevates the agency’s demands for medical device cybersecurity, but the agency advised industry in a recent webinar that hospital IT systems are fraught with cybersecurity hazards of their own, and thus device makers should view these IT systems as potentially hostile environments where cybersecurity is concerned.
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U.S. flag, stethoscope

Cook’s Echo Tip comes up short in Medicare outpatient final rule, but Philips’ Cavaclear scores

Nov. 7, 2023
By Mark McCarty

The U.S. Centers for Medicare & Medicaid Services (CMS) has wrapped up its rulemaking for the outpatient prospective payment system (OPPS) for calendar year 2024, bringing some good news and some bad news for the medical device industry. While Philips North America came home with a new technology pass-through (NTPT) payment for its Cavaclear device, Cook Medical Inc., was less fortunate with its Echo Tip device as CMS declared that the Echo Tip did not satisfy the substantial clinical improvement criteria for transitional pass-through payment.


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U.S. Capitol building
FDLI Advertising and Promotion Conference

US data privacy environment a tangled web for med-tech companies

Nov. 3, 2023
By Mark McCarty
Privacy considerations have been front and center for U.S. federal government agencies for more than two decades, but several states have jumped into the privacy arena with their own legislative imperatives. While companies in the medical device industry would like to see a less imposing thicket of related enforcement requirements, Nancy Perkins of Arnold & Porter LLP said there is little prospect that Congress will relieve the predicament with anything resembles preemptive legislation.
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UK's MHRA reports the launch of Airlock program for AI

Nov. 1, 2023
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has converted its regulatory sandbox for artificial intelligence (AI) into a full-fledged program dubbed the AI-Airlock, described as a regulatory-monitored virtual area in which industry can “generate robust evidence for their advanced technologies.” MHRA said it is focused on ensuring that AI products are available in the U.K. “before they are available anywhere else in the world,” a sign that national economic competitiveness is fostering a regulatory willingness to deal with uncertainty about this class of products.
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