AI and machine learning products have proven complicated for regulatory authorities across the globe, but entities in the business of conducting health technology assessments also have their hands full according to several sources.

The amounts invested in third-party litigation funding (TPLF) are expected to increase more than three-fold in the coming years, and the U.S. Congress has finally taken note of the predicament. Both the House and the Senate have introduced bills to tackle the problems of TPLF.

The U.S. Centers for Medicare & Medicaid Services proposed to use AI to cut down on abuse of the Medicare program, but several members of Congress have concerns about the notion, given that private payers have used AI to illegitimately deny services to their beneficiaries.

In a regulatory round-up, the U.K. Medicines and Healthcare Products Regulatory Agency opened a survey regarding in-house device manufacturing, the EU Notified Bodies staffed up last year and the Singapore Health Sciences Authority and the Hong Kong Department of Health agreed to share information.

The U.S. Centers for Medicare & Medicaid Services proposed to use AI to cut down on abuse of the Medicare program, but several members of Congress have concerns about the notion, given that private payers have used AI to illegitimately deny services to their beneficiaries.

The reach of the med-tech patent wars now includes devices for electroencephalography thanks to a complaint recently filed by Sunnyvale, Calif.-based Ceribell Inc. with the U.S. International Trade Commission. The company alleged infringement of six of its patents by two units under the Natus umbrella of companies, but this conflict is also under review in Delaware district court, promising a drawn-out conflict that may not resolve for years.

The issues facing the EU’s Medical Device Regulation and the In Vitro Diagnostic Regulation are the stuff of legend, but the EU’s notified body group, TEAM NB, has proposed a mechanism to deal with some of the administrative problems.

The FDA’s warning letter to Whoop Inc. resurrects questions about the agency’s observance of the 21st Century Cures Act in that the warning letter stakes out the position that any reading of blood pressure is “inherently associated” with hypertension.

Eleven pages is relatively short for a modern U.S. FDA draft guidance, but two trade associations nonetheless had questions about the FDA draft for transfers of 510(k) devices, such as how the agency defines the holder of the 510(k).

Kingsley Chin, the CEO of Spinefrontier Inc., has been sentenced to a year of supervised release for his role in the payment of less than $5,000 in consulting fees to a surgeon who provided no consulting services.