On December 14, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published in the Federal Register a request for information (RFI) titled “Modifying HIPAA Rules to Improve Coordinated Care.” The RFI seeks public input on a broad range of potential reforms to Health Insurance Portability and Accountability Act (HIPAA) regulations with a focus on enhancing care coordination. Though only a preliminary step on the path to potential regulatory reform, the RFI’s scope is significant, as is the opportunity it affords stakeholders interested in sharing early input as HHS considers reforms to key health information privacy requirements. (more…)
The National Association of Insurance Commissioners (NAIC) held its Fall 2018 National Meeting (Fall Meeting) in San Francisco, California, from November 15 to 18, 2018. This post summarizes the highlights from this meeting. (more…)
The U.S. Department of Commerce, Bureau of Industry and Security (BIS) has published an advance notice of proposed rulemaking (ANPRM) initiating a 30-day public comment process regarding export controls for certain emerging technologies. The notice launches the implementation of a key provision of the Export Control Reform Act of 2018 (ECRA), part of the National Defense Authorization Act for fiscal year 2019 (NDAA). In the ECRA, Congress authorized BIS to establish controls on the export, reexport and transfer (in country) of “emerging and foundational technologies.” The ANPRM, including a list of the 14 proposed representative technology categories and subcategories subject to review, can be found here. Our prior updates on the NDAA and ECRA can be found here.
The Administration is preparing to release a Request for Information (“RFI”) on potential modifications to Health Insurance Portability and Accountability Act (HIPAA) rules. The draft RFI was recently submitted by the Department of Health and Human Services (“HHS”) to the White House’s Office of Management and Budget (“OMB”) for pre-release review.
Three Boston-area hospitals collectively paid just under $1 million to settle allegations that they violated HIPAA by improperly disclosing patients’ identities and other protected health information during onsite filming of a television network documentary. According to the Department of Health and Human Services Office for Civil Rights (OCR)’s September 20, 2018 press release, the three hospitals – Boston Medical Center (BMC), Brigham and Women’s Hospital (BWH), and Massachusetts General Hospital (MGH) – permitted film crews to film an ABC television network documentary series on premises without first obtaining authorizations from patients. Collectively, the three hospitals paid $999,000 to settle potential violations of the HIPAA Privacy Rule, with BMC paying $100,000, BWH paying $384,000, and MGH paying $515,000.
On September 5, 2018, the new Belgian Data Protection Act implementing the GDPR (the Belgian Act) was published and entered into force. Despite the GDPR being an EU regulation that directly applies to all EU Member States, several provisions of the GDPR explicitly allow, and even require, Member States to enact legislation which implements the law. Member States were expected to have this legislation in place by May 25, 2018, but the majority of Member States (including Belgium) did not meet the deadline. Since December 2017, however, Belgium has had in place a law implementing many of the more procedural provisions of the GDPR, namely the Act on the Establishment of the Supervisory Authority (the SA Act). The SA Act lays down the structure, powers and competence of the new Belgian Supervisory Authority, and also includes rules of procedure applicable to administrative proceedings before the Authority. (more…)
On 21 August 2018, the Dutch Supervisor Authority announced that it had conducted an investigation into the designation of a Data Protection Officer (DPO) under the General Data Protection Regulation (GDPR) by 91 hospitals and 33 healthcare insurers in the Netherlands. Two hospitals had not yet communicated the contact details of their DPO to the Dutch Supervisor Authority, and were given four weeks to designate a DPO. In addition, the Supervisor Authority found that 25% of the hospitals and healthcare insurers whose practices were reviewed did not properly publish their DPO’s contact details on their website. They will also be expected to implement the necessary compliance measures. (more…)
*This article first appeared in the July 2018 issue of Digital Health Legal
Massive data breaches. Threats to medical devices. The Internet of Persons. Healthcare entities are all too familiar with the rising cyber threat. But they are also familiar with the complex array of laws and regulations in the United States that attempt to address the threat and the potentially significant compliance costs and risks caused by that complexity. The US Court of Appeals for the Eleventh Circuit’s recent and long-awaited decision in LabMD v. Federal Trade Commission, which trimmed the sails of one of the primary regulators of the healthcare information security landscape, may thus appear to some, at first blush, to be a necessary corrective. Yet closer inspection shows that the Eleventh Circuit’s decision raises more questions than it answers – and that its true implications will only become clear once we see how federal regulators, the courts, and perhaps Congress respond.
In a recent speech outlining the Trump Administration’s healthcare regulatory reform efforts, Secretary of Health and Human Services (HHS) Alex Azar announced that the Administration will soon begin considering changes to federal health privacy regulations. (more…)
Whether you are marking today with a glass of champagne, a shot of whiskey, or a hot cup of tea, today marks a significant day for privacy professionals world-wide.
Here’s to all of the privacy professionals who have put in so many hours to prepare for the GDPR, fully effective as of Friday May 25, 2018 at midnight in Brussels; that is 6 PM eastern on Thursday, May 24th for toasting purposes.
For business executives, policymakers, and consumers who have become aware of the GDPR in recent weeks and are interested in learning more, visit our GDPR resource page here.