On December 28, 2018, the U.S. Department of Health and Human Services (HHS) released a four-volume cybersecurity guidance document for healthcare organizations. The publication, “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP), is the result of a government and industry collaboration mandated by the Cybersecurity Act of 2015. The HICP is not limited to individually identifiable health information but instead covers organizations’ enterprise-level information security more generally. HHS describes the publication as “practical, understandable, implementable, industry-led, and consensus-based voluntary cybersecurity guidelines to cost-effectively reduce cybersecurity risks for healthcare organizations of varying sizes.” Notwithstanding their voluntary nature, these HHS-backed cybersecurity recommendations are likely to serve as an important reference point for the industry. (more…)
When the GDPR came into effect on May 25, 2018, several European Member States had yet to put in place further implementing legislation. And while the data protection world watches and eagerly digests each new interpretive guidance from data protection authorities, Member State legislation provides additional interpretive tones of harmony or discord in data protection across Europe. After much delay and almost seven months after the EU’s General Data Protection Regulation (“GDPR”) came into force, the Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital Rights (“LOPDGDD”) – which implements the GDPR in Spain – entered into force on 7 December 2018. (more…)
On December 17, 2018, European Commission Decision (EU) 2018/1996 (the ‘Decision’) was published in the Official Journal of the European Union. The Decision lays down rules designed to reconcile the rights of individuals respecting their personal data, with the need for effective trade defence and trade policy investigations in the EU. (more…)
With the midterm election out of the way, legislators on Capitol Hill and in state capitols are getting ready to consider the future of data privacy regulation in 2019 and consumer and industry groups continue to weigh in on the ongoing debate. The debate has begun to move from principles and frameworks to drafting of legislative language.
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…)
On November 23, 2018, the European Data Protection Board (“EDPB”) published draft guidelines seeking to clarify the territorial scope of the GDPR (“Guidelines”). The Guidelines have been eagerly awaited, particularly by controllers and processors outside of the EU looking for confirmation as to whether or not the EU data protection rules apply to them. The Guidelines largely reaffirm prior interpretations of the GDPR’s territorial application under Article (3)(1), and offer essential guidance with respect to the GDPR’s – heavily debated – extraterritorial application under Article (3)(2). The GDPR applies to companies established in the EU as well as companies outside of the EU that are “targeting” individuals in the EU (by offering them products or services) or monitoring their behavior (as far as that behavior takes place in the EU).
The proposed Guidelines are open for public consultation until January 18, 2019. It remains to be seen whether and how any outstanding issues will have been addressed upon conclusion of the consultation. (more…)
On November 16, the U.S. Securities and Exchange Commission (SEC) announced its first enforcement actions against issuers of initial coin offerings solely for failing to register the offerings in violation of the federal securities laws since Munchee (i.e., without allegations of fraud). Unlike the Munchee order, these settlements impose penalties against the issuers and require certain undertakings, such as registering the digital assets as securities under the Exchange Act. The same day, the SEC’s Divisions of Corporation Finance, Investment Management and Trading and Markets released a joint statement reiterating the SEC’s lessons from recent enforcement actions related to digital assets. (more…)
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.