The playing field in a lawsuit challenging agency action is tilted toward the agency, largely by means of various deference doctrines. One of the most important has been deference to an agency’s interpretation of its own regulations. Courts have been deferring to those interpretations for decades, following a 1940s Supreme Court case, Bowles v. Seminole Rock & Sand Co.[1] The ground really shifted in 1997, when in Auer v. Robbins[2] the Supreme Court…
The Delaware Supreme Court recently affirmed a decision by the Delaware Court of Chancery addressing a plaintiff’s ability to acquire key documents from a defendant company based on allegations against that company in an ancillary False Claims Act (FCA) complaint.  See UnitedHealth Group Incorporated v. Amalgamated Bank as Tr. for Longview Largecap 500 Index Fund, 2018 WL (Del.). The Underlying FCA Allegations In two separate federal districts, UnitedHealth Group Incorporated (United) faced unsealed, factually similar…
The Office for Civil Rights (OCR) is requesting public input on reforms to Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules to promote care coordination and the health system’s transformation to value-based health care while protecting the privacy and security of individuals’ protected health information (PHI).  Specifically, in a request for information (RFI) to be published on December 14, 2018, OCR seeks feedback on ways current policy could be modified the meet…
On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”).  In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top strategic priority for the FDA.”  FDA opened a docket for public comments on the Framework through February 5, 2019. The…
On December 10, 2018, the California Supreme Court handed down its unanimous decision in Gerard, et al. v. Orange Coast Memorial Medical Center, affirming the Court of Appeal ruling that voluntary meal period waivers are permissible for healthcare employees who work long shifts, even if they work more than 12 hours. By allowing healthcare employees to waive one of their two meal periods, the Gerard decision preserves a choice for employees who work 12-hour…
Federal regulators have warned nursing homes nationwide to improve the quality and safety of their patient care or face consequences that operators may hasten to heed. That’s because new penalties and rewards will hit them in a place that counts — their pocketbooks. Two-thirds of the nation’s nursing homes will see a year’s worth of their Medicare funding reduced, the nonprofit, nonpartisan Kaiser Health News Service (KHN) reported, “based on how often their residents ended…
The UK’s National Institute for Health and Care Excellence (NICE) has recently published an evidence standards framework for DHTs (the Standards), available here.  It did so through a working group led by NHS England, but supported by representatives from Public Health England, MedCity and DigitalHealth.London. The Standards cover DHTs, such as apps, programs and software – both standalone or combined with other products like medical devices or diagnostic tests – intended for use within…
The Office for Civil Rights has announced that it has fined Lakeland, Florida based Advanced Care Hospitalists (ACH) $500,000 for an impermissible disclosure of protected health information by one of its business associates. ACH provides contract internal medicine physicians to nursing homes and hospitals. According to the press release, between November of 2011 and June of 2012, ACH engaged an individual who claimed to be a representative of Doctor’s First Choice Billings, Inc. (First Choice),…
Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit. Topics Overview of the EU pharmaceutical law framework Clinical trials, unlicensed supply and compassionate use Obtaining marketing authorisations Incentives: regulatory data protection, marketing protection, orphan…
Pennsylvania’s Patient Test Result Information Act, which is set to take effect December 23, 2018, requires diagnostic imaging services providers that identify a “significant abnormality” in their test results to directly notify the patient or his/her designee within 20 days of the completed test, its review and its delivery to the ordering health care practitioner.  The new law defines the circumstances under which a patient notice is mandatory, as well as required information and language…