Tag Archives: Stuart M. Gerson

Supreme Court Refuses to Impose Class Action Arbitration Based on Ambiguous Agreements

Our colleague Stuart M. Gerson at Epstein Becker Green recently posted an article on LinkedIn that will be of interest to our readers: “SCOTUS Today: Class Action Ambiguity Finds No Shelter Under the Federal Arbitration Act.”

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NIST Seeks Comments on Cybersecurity Standards For Patient Imaging Devices

Our colleague  at Epstein Becker Green has a post on the Health Law Advisor blog that will be of interest to our readers in the technology industry: “NIST Seeks Comments on Cybersecurity Standards For Patient Imaging Devices.”

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The GDPR Soon Will Go Into Effect, and U.S. Companies Have to Prepare

The European Union’s (“EU’s”) General Data Protection Regulations (“GDPR”) go into effect on May 25, 2018, and they clearly apply to U.S. companies doing business in Europe or offering goods and services online that EU residents can purchase. Given that many U.S. companies, particularly in the health care space, increasingly are establishing operations and commercial relationships outside the United States generally, and in Europe particularly, many may be asking questions akin to the following recent inquiries that I have fielded concerning the reach of the GDPR:

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Compliance Enforcement Pressure is Increasing for Directors

Both the Department of Justice and the Department of Health and Human Services Inspector General have long urged (and in many cases, mandated through settlements that include Corporate Integrity Agreements and through court judgments) that health care organizations have “top-down” compliance programs with vigorous board of directors implementation and oversight. Governmental reach only increased with the publication by DoJ of the so-called Yates Memorandum, which focused government enforcers on potential individual liability for corporate management and directors in fraud cases. Thus, if it isn’t the case already, compliance officers should assure that senior management and directors are aware of their oversight responsibilities and the possible consequences if they are found not to have fulfilled them.

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Sharing Cyber Threat Information

The Information Sharing and Analysis Organization-Standards Organization (ISAO-SO) was set up under the aegis of the Department of Homeland Security pursuant to a Presidential Executive Order intended to foster threat vector sharing among private entities and with the government. ISAOs are proliferating in many critical infrastructure fields, including health care, where cybersecurity and data privacy are particularly sensitive issues given HIPAA requirements and disproportionate industry human and systems vulnerabilities. Therefore, in advising their companies’ management, general counsel and others might benefit from reviewing the FAQ’s and answers contained in the draft document that can be accessed at the link below.

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U.S. Supreme Court Rules in Favor of Liberty Mutual

Stuart Gerson

Today, the U.S. Supreme Court decided (6-2, with Kennedy writing for the majority and  Ginsburg and Sotomayor dissenting) the case of Gobeille v. Liberty Mutual Insurance Co.  The matter before the Court involved Vermont law requiring certain entities, including health insurers, to report payments relating to health care claims and other information relating to health care services to a state agency for compilation in an all-inclusive health care database.

In an important victory for pre-emption advocates, the Court held that this law was pre-empted by The Employee Retirement Income Security Act of 1974 (ERISA) which expressly pre-empts “any and all State laws insofar as they may now or hereafter relate to any employee benefit plan.” And that includes any  state law that has an impermissible “connection with” ERISA plans, i.e., a law that governs, or interferes with the uniformity of, plan administration.  

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