Will Patents Become More Political? The PTO Begins to Implement Arthrex

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 to the U.S. Supreme Court’s decision in United States v. Arthrex.

To resolve the inconsistency, the Supreme Court vested the USPTO Director, who is a principal officer, with authority and discretion to grant rehearing of PTAB Final Written Decisions (FWDs) regarding patentability of challenged patent claims. The Supreme Court held, “What matters is that the Director have the discretion to review decisions rendered by APJs. In this way, the President remains responsible for the exercise of executive power—and through him, the exercise of executive power remains accountable to the people.”  You can read more about this topic on our Global IP & Technology Law Blog here.

FDA Revokes EUAs for Certain Non-NIOSH Respirators – A Sign of More to Come?

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 May 27, 2021 letter to healthcare personnel and facilities recommending a transition away from non-NIOSH FFRs approved by the agency under the EUAs. The June announcement specifically revoked the following three EUAs:

• Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
• Imported Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
• Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)

Additionally, the agency withdrew two-related decontamination and bioburden reduction guidance documents:

• Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff
• Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease (2019) Public Health Emergency Continue Reading

Supreme Court Upholds the Affordable Care Act…Again

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 Justice Thomas also writing a concurring opinion. Justice Alito wrote a dissenting opinion in which Justice Gorsuch joined. The decision ends the uncertainty that has surrounded the ACA ever since a Texas district court ruled that the ACA was unconstitutional, and puts the law back on solid footing, at least for now. Continue Reading

Healthcare Employers Take Note: OSHA Issues New Temporary Standard

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 that OSHA likely will issue specific COVID-19 standards for other industries in the near future.

The standard imposes several specific requirements.  It requires covered entities to conduct hazard assessments, maintain written plans designed to mitigate the spread of COVID-19, and provide specific protective equipment to certain employees (including N95 respirators in certain circumstances).  It also requires covered employers to take specific steps to maintain six foot distancing between employees (as well as between employees and others in certain situations).  It contains new rules requiring covered employers to take steps to separate any employees  with COVID-19 from others by providing certain leave and remote working options to those employees, as well as providing leave to employees in order to get vaccinated.  It does, however, exempt fully vaccinated employees from certain masking, distancing, and barrier requirements when there is no reasonable expectation that any person will be present in the same defined area who may have or did contract coronavirus.

As most healthcare employers know, OSHA and other agencies have been particularly vigilant in monitoring and enforcing safety-related obligations in the healthcare space.  So, even though many entities already were taking many (if not all) of these steps even before the standard, it is important for covered employers to review the standard in detail and ensure they are satisfying all of the specific requirements.  OSHA provided a more detailed fact sheet concerning the rule here and provided the full text here. The rule will become effective in the near future (as soon as it is published in the federal register), and employers must begin complying with many provisions within 14 days after that (and with all provisions within 30 days).

Finally, this new rule serves as a reminder that government entities are not yet finished updating their rules and guidance concerning COVID-19.  Even though the spread has decreased, all employers should expect federal, state, and local authorities to continue issuing updates and changes for at least the near future, and should continue monitoring for guidance from entities such as the Department of Labor (including OSHA), the CDC, the EEOC, as well as state and local agencies.

Updated: Ohio Hospitals May Soon be Subject to License Requirements

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. Continue Reading

Webinar: Got Data?: How the Health Data Rules are Changing

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 amend the HIPAA regulations. Additionally, the webinar will cover recent and upcoming modifications to the 42 CFR Part 2 rules and the interplay between health data regulations and state privacy laws, such as the California Consumer Privacy Act (CCPA), California Privacy Rights Act (CPRA), and Virginia Consumer Data Protection Act (CDPA).

Additional information about the session and registration may be found here.

Healthcare Tech Deal Falls Foul of UK CMA’s Harder Line on Merger Control

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 to NHS Spine (the IT infrastructure for health and social care in England). Continue Reading

The Medical Device Regulation, COVID-19 and Brexit

Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the date of application of certain provisions of Regulation 2017/745 (MDR) by one year.  The Regulation was published on 24 April 2020 through an EU accelerated procedure, and although the COVID-19 pandemic is still a major issue, the expiry of the one-year deferral is fast approaching.

The Regulation recognised that the COVID-19 outbreak and the associated public health crisis presented an unprecedented challenge to EU member states and constituted an immense burden for national authorities, health institutions, Union citizens and economic operators. Further, it recognised that the public health crisis created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of the MDR.

The Regulation effectively provided considerable regulatory easement for the medical device industry, Notified Bodies and EU regulators, and with a view to allow more directed action against the pandemic.

This publication addresses what will change under MDR, the impact of Brexit and the practical impact of this move.  You can read more about this in our client alert, available here.

Federal Appellate Court Tosses Out HIPAA Penalty for Healthcare Data Breaches, Criticizes OCR

In a dramatic rebuttal of how the Department of Health and Human Services Office of Civil Rights’ (“OCR”) has historically enforced HIPAA with potential far-ranging consequences, the Fifth Circuit Court of Appeals recently handed down a landmark decision criticizing and restricting how OCR interprets HIPAA and OCR’s penalty authority.  OCR brought an enforcement action against the University of Texas M.D. Anderson Cancer Center (“M.D. Anderson”) stemming from three separate alleged data breaches and violations of various HIPAA requirements. OCR imposed a US$4,348,000 penalty, which M.D. Anderson appealed.  The case eventually reached the Fifth Circuit Court of Appeals.  In rejecting the penalty, the Court criticized not only OCR’s interpretation of the HIPAA regulations generally but also OCR’s penalty calculation in this case.  Our report on the decision prepared by Elliot GoldingKristin Bryan and Christina Lamoureux is available here

Biden Administration 60-day Regulatory Freeze

On Wednesday, January 20, 2021, President Biden’s chief of staff, Ronald A. Klain, circulated a memorandum (memo) to the heads of federal executive departments and agencies outlining an Executive Action implementing a 60-day freeze on any new or pending regulations. This is a customary practice for new administrations. The freeze allows the administration to conduct an appropriate review of these rules to determine if there is any conflict with the President’s policy objectives. Both the Obama and Trump administrations issued nearly identical Executive Actions on their first day in office.

This publication provides additional background on this action and provides a list of regulations in the health and life science fields that the memo may affect.  You can read more about it in our client alert, available here.

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