In United States v Arthrex, the Supreme Court held that 35 U.S.C. §6(c), which sets forth the authority of Patent Trial & Appeal Board (“PTAB”) Administrative Patent Judges (“APJs”), is unconstitutional because APJs effectively wield the power of principal officers (who require Senate confirmation) while being appointed as inferior officers (who do not require Senate confirmation). The U.S. Patent and Trademark Office has begun charting its path forward for devising and implementing agency rules in response…

More than a year after issuing Emergency Use Authorizations (“EUAs”) for filtering facepiece respirators (“FFRs”), surgical masks, and related personal protective equipment (“PPE”), the Food and Drug Administration (“FDA”) is walking back these measures. On June 30, 2021 the FDA announced the revocation of the EUAs for all imported, disposable FFRs not approved by the National Institute of Occupational Safety and Health (“NIOSH”) and related decontamination and bioburden reduction systems. The decision follows the agency’s…

For a third time, the Supreme Court has declined to strike down the Affordable Care Act (the “ACA”), this time in a 7-2 ruling in the case of California v. Texas. The Court held that Texas and the 17 other challenging states (the “Plaintiffs”) did not have standing to challenge the ACA, avoiding the need for the Court to decide the main questions raised by the litigation. Justice Breyer authored the majority opinion, with…

Since the outbreak of COVID-19, the Occupational Safety and Health Administration had limited itself to issuing general guidance concerning COVID-19, as opposed to specific rules or standards.  On Thursday, however, OSHA announced that it will issue its first standard specific to COVID-19 for healthcare workers.  Although the standard is temporary, it creates significant obligations for healthcare systems, assisted living facilities, home healthcare providers, and other OSHA-covered entities that employ healthcare workers.  It also further signals…

Unlike most other states, Ohio does not currently have a hospital licensure system. While Ohio hospitals are subject to registration and information reporting requirements, as well as licensure requirements for certain discrete hospital services, Ohio does not require hospitals to obtain a state license in order to operate. That may change if certain provisions in Ohio’s current budget bill are adopted.…

On June 1, SPB Partner Elliot Golding and other industry experts will co-present on the ABA Webinar: Got Data?: How the Health Data Rules are Changing. The program, organized by the American Bar Association (ABA) will address recent and upcoming developments impacting health data including, CMS and ONC final rules on information blocking and interoperability, HIPPA and guidance related to COVID-19, OCR enforcement priorities and trends (including audit results), and the recent Notice of Proposed Rulemaking to…

Yet another UK Competition and Markets Authority (CMA) merger referral for in-depth investigation, this time in the healthcare sector confirming the CMA’s willingness “to ensure that the NHS does not pay significantly more than it should” for products/services.[1]   The merging parties, Imprivata and Isosec, provide similar Identity and Access Management (IAM) solutions that allow staff of healthcare customers (incl. NHS entities) to access sensitive patient data – in particular, that gives them access…