The U.K. National Institute for Health and Care Excellence (NICE) has seen the nation’s spending numbers for diabetes, which is said to account for roughly 10% of healthcare spending in the U.K., and responded in a collaboration with the National Health Service (NHS).
A number of recent developments in artificial intelligence (AI) have sent some reassurance that these algorithms will not hit the market completely devoid of regulation, but a Nov. 8 hearing in the U.S. Senate makes clear that Capitol Hill is intent on legislating on AI, even if only belatedly.
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.
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.
The U.S. Centers for Medicare & Medicaid Services has followed through on an earlier threat to reduce payments for various sorts of radiology services in the physician fee schedule, including those invoked during episodes of cancer care, but Congress may yet intervene.
The U.S. Department of Justice (DOJ) has a unique role in enforcement of medical product communication even though the department shares oversight of medical product promotions with the FDA and the Federal Trade Commission (FTC).
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.
As a follow-up to the Biden administration’s executive order for artificial intelligence (AI), the U.S. Office of Management and Budget (OMB) has promulgated a memorandum directing federal government agency use of AI.
The U.S. Department of Justice (DOJ) has a unique role in enforcement of medical product communication even though the department shares oversight of medical product promotions with the FDA and the Federal Trade Commission (FTC).
As a follow-up to the Biden administration’s executive order for artificial intelligence (AI), the U.S. Office of Management and Budget (OMB) has promulgated a memorandum directing federal government agency use of AI.