Data privacy laws are springing up more regularly in the past couple of years, including in several U.S. states, but Congress seems inclined to step in to avoid a patchwork of regulations across the 50 states. The House Energy and Commerce Committee gave a ringing endorsement of new legislation via a 53-2 vote for H.R. 8152, a bill that would largely preempt the growing list of state privacy laws, but makers of health apps and other digital products might eventually be subject to private litigation under the terms of the bill.
Illumina Inc.’s acquisition of Grail Inc., of Menlo Park, Calif., may or may not prove to be a case of jumping the regulatory gun, but the move to date has not racked up significant financial penalties for the company. That may soon change per a statement by the European Commission, which said that Illumina may find itself on the receiving end of “hefty fines,” a statement made by EC executive vice president Margrethe Vestager.
The effects of U.S. Supreme Court case law on patents are well demonstrated, but the latest victims of patent jurisprudence are directed toward a critical need for desperately ill patients. The Court of Appeals for the Federal Circuit ruled that several claims found in three patents licensed to Caredx Inc., of Brisbane, Calif., are ineligible due to a purported lack of inventiveness under Section 101 of the Patent Act, an outcome that sustains what some believe is a trend in case law that is hostile toward diagnostic patents in the U.S.
The U.S. CMS released the draft Medicare hospital outpatient rule for calendar year 2023, a document that is replete with information on pass-through payment data for drugs and devices. However, the agency said that the Supreme Court’s ruling regarding rates for drugs covered under the 340B drug pricing program came too late in the annual cycle to be fully accounted for in the outpatient rule for 2023, and thus any such permanent adjustments will have to wait until the outpatient rule for 2024.
The U.S. federal government’s crackdown on companies in the health care space shows no signs of slowing down as indicated by an announcement by the Department of Justice (DOJ) that it has achieved a settlement with Opko Health Inc. and Bioreference Health LLC regarding allegations of induced referrals.
Reliance Medical Systems LLC agreed to pay $1 million to address allegations of violation of the Anti-Kickback Statute (AKS), but the company has responded to that outcome with a blistering riposte.
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.
