The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.
Illumina Inc., of San Diego, is struggling to complete the regulatory side of its acquisition of Grail Inc., of Menlo Park, Calif., thanks in part to the U.S. Federal Trade Commission’s (FTCs) ongoing review of the transaction. However, Illumina is also facing stiff winds in Europe where the General Court of the European Union rejected the company’s bid to push the deal through despite the opposition of the European Commission (EC).
The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.
The U.S. Department of Justice (DOJ) has filed a complaint in civil court against Fresenius Vascular Care Inc., of Berwyn, Pa., alleging the company had performed unnecessary procedures in nine clinics in the New York area. When paired with a recent Supreme Court case that went against Davita Inc., of Denver, this action may signal a source of pressure on dialysis services in the U.S., a set of developments that have already cost both these companies significantly on the stock market.
The U.S. FDA’s two-day meeting of the patient engagement advisory committee (PEAC) covered a range of issues surrounding augmented reality (AR) and virtual reality (VR) products, but patient information and education was one of the key considerations. Naiem Nassiri of Yale Medicine cautioned, however, that a 15-minute briefing between doctor and patient during a face-to-face encounter would likely create more confusion than clarity, a conclusion that would suggest that other patient education methods will likely be needed.
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff.
The U.S. Federal Trade Commission (FTC) has been moving aggressively on privacy issues in connection with health data in the past two years, but the agency has issued an advisory of sorts to collectors of these data points. The FTC said July 11 that it intends to crack down on violators in an effort to protect data privacy.
The U.S. FDA’s third-party review program for 510(k) filings has perhaps never quite lived up to expectations that this program would take a significant load off the FDA’s shoulders, and the latest quarterly report does nothing to detract from that perception.
The U.S. CMS posted the draft Medicare physician fee schedule (MPFS) for calendar year 2023, and advocates of telehealth will be cheered by a proposed extension of some pandemic-driven telehealth services throughout 2023. The draft is less generous in connection with external electrocardiogram patches in a move that could ding Irhythm Technologies Inc., and its Zio XT device, but analysts at BTIG predict that any hit to reimbursement rates is likely to be offset with greater sales volumes, leaving Irhythm and its investors in a solid place going forward.
The U.S. FDA’s rule for over-the-counter (OTC) hearing aids was several years late coming out, but the rule has nonetheless proven controversial from the outset. Two members of the U.S. Senate have blasted device makers for what they allege is interference with the rulemaking process via “astroturf” campaigns to prod hearing aid users to influence the agency’s final rule.
