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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

Cyber security padlock

HHS floats much more stringent set of HIPAA security measures

Jan. 6, 2025
By Mark McCarty
Makers of digital health apps are not often subject to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), but any such liabilities may soon become more onerous. The Department of Health and Human Services released a draft update for HIPAA cybersecurity mandates – the final version of which is sure to be accompanied by much more vigorous enforcement.
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AI biotech research concept with lightbulb and digital background

FDA inks draft guidance for AI applicable across product centers

Jan. 6, 2025
By Mark McCarty
Some people may have seen 2024 as the year of artificial intelligence (AI) in med tech, but the FDA is off to a strong start in 2025 with a dual-purpose AI draft guidance. While the draft covers both premarket submissions and life cycle management considerations, the more important consideration is that the FDA’s centers for devices, drugs and biologics have all signed off on the draft, suggesting an agency-wide convergence in thinking about AI.
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Hourglass on glowing circuit board, symbolizing time and technology
Year in review

EU’s med-tech regulatory struggles continue into 2025

Jan. 3, 2025
By Mark McCarty
Regulatory overhauls are never a simple affair, but the med tech industry ran into an amorphous, ennui-inducing mess in dealing with the EU Medical Device Regulation almost immediately. Even though the underlying legislation passed in 2017, the MDR impasse continued to impede innovation on the continent – a problem that might be only partly resolved in 2025.
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Medicare puzzle
Year in review

Medicare coverage issues abound in 2024

Jan. 2, 2025
By Mark McCarty
The device industry is extraordinarily dependent on administrative activity where Medicare coverage is concerned, and this was exceptionally evident in 2024 when software and digital health coverage policies remained bogged down.
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Regulatory icons
Year in review

FDA’s device center vigorously stirred the regulatory pot in 2024

Dec. 31, 2024
By Mark McCarty
2024 was a critical year for the FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but two lawsuits over the final rule for regulation of lab-developed tests, a problem that promises to distract the agency throughout 2025 and potentially beyond.
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U.S. FDA headquarters

FDA wary of overreporting of clinical study protocol deviations

Dec. 31, 2024
By Mark McCarty
The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related compliance activities.
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AI biotech research concept with lightbulb and digital background
Year in review

Regulatory developments for AI gained momentum in 2024

Dec. 30, 2024
By Mark McCarty
Artificial intelligence (AI) is no novelty for medical technology, but 2024 saw an interesting series of events in this area from across the globe. While some of these developments portend immediate regulatory clarity, some are harbingers of continued regulatory flux in 2025 and beyond.
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Magnifying glass atop paperwork

FDA recounts problems with CDS, but no denominator offered

Dec. 30, 2024
By Mark McCarty
The U.S. FDA has issued a second report in connection with device software functions, which includes surveillance data for clinical decision support (CDS) tools. While the report lists three events that qualify as adverse events, the FDA offered no information that would provide an adverse event rate for CDS products.
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Gears with regulatory words
End of Year

2025 the year device makers need to rework quality management system

Dec. 27, 2024
By Mark McCarty
Device makers doing business in the U.S. have had a much more stable regulatory regime than has been true for companies in other jurisdictions, but that will shift somewhat in 2025. Brynn Stanley of Gardner Law told BioWorld that manufacturers should get busy with the U.S. FDA-mandated do-over of their quality management systems as the compliance deadline of February 2026 does not generally permit procrastination.
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Illustration demonstrating data flow from patient to doctor
End of Year

Firms may still be wary of responding to misinformation in 2025

Dec. 24, 2024
By Mark McCarty
The U.S. FDA’s newest draft guidance for dealing with medical product misinformation might seem to signal a cooperative attitude toward misinformation on the agency’s part, but regulatory attorney Daniel Kracov told BioWorld that the disincentives for doing so might still outweigh the incentives despite the reworked draft guidance.
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View All Articles by Mark McCarty

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