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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

2024 ACLA Annual Meeting

US Medicare coverage for AI seen as ‘a train wreck’

March 14, 2024
By Mark McCarty
Medicare coverage of medical software in the U.S. is generally not the subject of flattering remarks from industry, but the novelty of the subcategory of artificial intelligence (AI) would seem to suggest that the Medicare problem for AI is even more severe. That suspicion was borne out by consultant Bruce Quinn who said at a public meeting here in Washington that some areas of software coverage and reimbursement, including AI software, “are just a train wreck,” a problem he said is especially acute in fee-for-service care.
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U.S. flag on columned building

US circuit court case a bright spot for defendants in FCA cases

March 13, 2024
By Mark McCarty
The news about how the U.S. False Claims Act (FCA) is adjudicated in the courts is typically dismal, but the U.S. Court of Appeals for the Ninth Circuit recently provided an exception.
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Ribbons of digital data

European Parliament passes Artificial Intelligence Act

March 13, 2024
By Mark McCarty
The European Parliament (EP) has passed the Artificial Intelligence Act (AI Act), bringing the legislation one step closer to full passage into law, with passage by the European Council the only remaining hurdle.
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US DOJ sets more aggressive course for qui tam activity

March 12, 2024
By Mark McCarty
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence. However, the more important take-away, according to Preston Pugh of Crowell & Moring LLP, is that the Department of Justice (DOJ) continues to work to make the legal environment more friendly to would-be whistleblowers, thus increasing the risk for companies inside and outside the life sciences.
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World map with connecting lines
2024 IMDRF Annual Meeting

Med-tech regulatory flux in play across the globe

March 12, 2024
By Mark McCarty
Regulatory harmonization and reliance are the orders of the day at this year’s meeting of the International Medical Device Regulators Forum (IMDRF), but that does not mean individual regulators are waiting for IMDRF to act on their own imperatives.
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U.S. FDA headquarters

Manufacturing change prompts removal of Cardinal’s Monoject

March 12, 2024
By Mark McCarty
The U.S. FDA announced March 7 that Cardinal Health of Dublin, Ohio, has expanded a product correction for Monoject devices to a product removal because of manufacturing changes that could affect product performance.
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Global market charts
2024 IMDRF Annual Meeting

Regulatory reliance emphasized at IMDRF meeting

March 11, 2024
By Mark McCarty
This year’s annual meeting of the International Medical Device Regulators Forum (IMDRF) revolves around regulatory reliance, a notion that approaches but does not quite stray into the realm of the mutual recognition agreement.
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Gavel and scales

US DOJ sets more aggressive course for enforcement activity

March 11, 2024
By Mark McCarty
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence (AI).
Read More
Ivenix

Fresenius feels compliance whiplash from Ivenix acquisition

March 7, 2024
By Mark McCarty
The U.S. FDA’s warning letter to Fresenius Kabi AG of Homburg, Germany highlighted several problems with the compliance practices at the company’s plant in North Andover, Mass., but there is more than just a compliance issue at play. Fresenius had acquired the Ivenix infusion pump and the inspected research and development site in its 2022 acquisition of Ivenix Inc., another example of the regulatory and compliance hazards of acquisitions in the med-tech space.
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WTO logo

WTO steps back from renewal of IP waivers for COVID

March 6, 2024
By Mark McCarty
The World Trade Organization wrapped up its 13th ministerial conference and, as the saying goes, no news is good news. Life science trade associations in the U.S. lauded the end of the conference without an extension of intellectual property rights waivers for therapies and diagnostics for the COVID-19 pandemic, although this outcome was not entirely surprising.
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