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.

AHLA Podcast: Labor and Employment Issues with COVID-19 Vaccine Distribution

Squire Patton Boggs Of Counsel Will Kishman recently participated with Kristin McGurn, Seyfarth Shaw LLP, in an American Health Law Association’s (AHLA) Speaking of Health Law podcast, “Labor and Employment Issues with COVID-19 Vaccine Distribution.”  It has been published on the AHLA’s Speaking of Health Law channel, and is available to the public.  You may access the podcast here.

This timely podcast covers employment issues related to COVID-19 vaccine distribution. The speakers talk about the recent EEOC guidance, including what employers should do about employee objections to the vaccine, and what sort of accommodations must be made in this regard. The program also discusses labor union issues, liability protections, and other state and federal guidance.

UnitedHeathcare Subsidiary Indicted for No-Poach Agreements

The Department of Justice kicked off 2021 with its first publicly filed, two-count indictment against Surgical Care Affiliates, LLC (SCA) and successor entity Scai Holdings, LLC, both accused of criminal antitrust violations for agreeing with other healthcare companies not to solicit each other’s senior-level employees. The charges are the first to come out of an ongoing investigation by the Antitrust Division into alleged no-poach agreements between employers.

The indictment alleges that SCA entered into two bilateral no-poach conspiracies. One agreement between SCA and a Texas based company ran from May 2010 until October 2017. The second agreement, spanning from February 2012 until July 2017, was between SCA and a Colorado based company for the same prohibitive acts.

“The charges demonstrate the Antitrust Division’s continued commitment to criminally prosecute collusion in America’s labor markets,” Assistant Attorney General Makan Delrahim said in a statement. “A freely competitive employment market is essential to the health of our economy and the mobility of American workers. Along with our law enforcement partners, the division will ensure that companies who illegally deprive employees of competitive opportunities are not immune from our antitrust laws.” Continue Reading

Pharmaceuticals Highlighted in the EU-UK Trade and Cooperation Agreement

The EU-UK Trade and Cooperation Agreement (the Agreement), announced just before Christmas, has now been agreed by the UK Parliament and EU Commission. This is now in place with a requirement for further approval by the EU Parliament. The Agreement is wide-ranging but in terms of trade mainly focusses on the supply of goods. As one of the most highly regulated sectors, pharmaceuticals are highlighted in a number of areas with specific provisions that touch on regulatory and intellectual property matters. Continue Reading

Election 2020 Puts Cannabis Center Stage

The cannabis industry was center stage during the November election, collecting a trove of wins making recreational marijuana legal now in 15 states and approved it for medical use virtually nationwide. The overwhelming nods in the recent election made marijuana more mainstream across the country and proved the cannabis industry has built a profound and powerful voice when it comes to messaging and revenue-building in states.

The multiple victories for cannabis on state ballots across the nation are the freshest evidence yet that American attitudes toward cannabis have been transformed. In an era of hyperpartisanship, cannabis reform is one of the few issues that is bringing Americans of different political affiliations and ideologies together. Continue Reading

CMS Publishes Stark Law Final Rules-Updated

In follow up to our post last month, on Wednesday, December 2, The Centers for Medicare and Medicaid Services (CMS) published final rules implementing many of the Stark Law changes first proposed in October 2019 (the Final Rules).

These changes have been adopted to address the shift to a value-based and coordinated healthcare environment. The Final Rules represent CMS’s recognition that the healthcare delivery and payment environment has changed from the “fee-for-service” model under which the Stark Law was developed, and that, in its current form, the Stark Law can impede the development of value-based relationships. In connection with this change, the Final Rules introduce new Stark Law exceptions and revise or re-evaluate many existing Stark Law exceptions and definitions.  You can read our summary of the changes in our latest client alert, available here.

UPDATE:  In December, the Government Accountability Office (GAO) found that the Final Rules’ January 19, 2021 effective date violated the Congressional Review Act, which requires major rules to have a 60-day delay in the effective date from the date of publication in the Federal Register.   This, together with the Biden administration’s recent Regulatory Freeze memo could be used to delay the Final Rules’ effective date.  You can read more about it here.