On December 28, 2018, the Department of Health and Human Services (HHS) issued new voluntary cybersecurity guidance for the health care industry titled, “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients.” This four-volume set of consensus-based principles and practices (the “HICP”) reflects the recommendations of the 405(d) Task Group, a HHS and industry-led collaborative task group named for Section 405(d) of the Cybersecurity Act of 2015, a provision that calls for a more coordinated approach to cybersecurity in the health care industry. The HICP […] Read more
Last Friday, the California Senate and Assembly passed SB-1121, amending the California Consumer Privacy Act (“CCPA”) as enacted in June. We previously issued an advisory following the June enactment, and will host a webinar discussing the law (as now amended) on September 12. This blog post highlights some of the key amendments to the CCPA. SB-1121 amends the CCPA as follows: Exemptions for Health Providers. The bill clarifies that the CCPA does not apply to protected health information (“PHI”) or medical information governed by the Health Insurance Portability and Accountability […] Read more
The U.S. Court of Appeals for the Eleventh Circuit recently issued its opinion in LabMD, Inc. v. FTC, No. 16-16270 (11th Cir. June 6, 2018), declaring unenforceable a Federal Trade Commission (FTC) order requiring LabMD to implement an extensive cybersecurity plan. The case is noteworthy for its lengthy procedural background—during which time LabMD became defunct—and its holding, which has called into question the FTC’s authority to impose wide-ranging, comprehensive cybersecurity plans.
The LabMD matter dates to 2005, when LimeWire file sharing software was installed on a company computer, [...] Read more
“To Harmonize or Not To Harmonize: That Is the Question.” With the the GDPR fast approaching on May 25, 2018, European Member States are getting ready with the implementation of national legislation. Although the GDPR is a regulation, and directly applicable in all Member States, it has left room for country-specific legislation in several different regards (such as the processing of employee data or individual rights restrictions). Most Member States still only have draft legislation at this point, but the expectation (or at least intention) is that each country will have adopted legislation [...] Read more
Over the past year, the German government has been working on legislation to implement the EU’s General Data Protection Regulation (GDPR). On July 6, 2017, Germany did so by passing a statute titled the Data Protection Amendments and Implementation Act. The Act repeals Germany’s venerated Federal Data Protection Act (Bundesdatenschutzgesetz, or BDSG) and replaces it with an entirely new BDSG, aptly referred to as the “BDSG-New.” Germany becomes the first EU Member State to pass a GDPR implementation statute. Given Germany’s reputation as one of, if not the, most serious privacy jurisdiction [...] Read more
Over the past year, the German government has been working on legislation to implement the EU’s General Data Protection Regulation (GDPR). On July 6, 2017, Germany did so by passing a statute titled the Data Protection Amendments and Implementation Act. The Act repeals Germany’s venerated Federal Data Protection Act (Bundesdatenschutzgesetz, or BDSG) and replaces it with an entirely new BDSG, aptly referred to as the “BDSG-New.” Germany becomes the first EU Member State to pass a GDPR implementation statute. Given Germany’s reputation as one of, if not the, most serious privacy jurisdiction [...] Read more
Over the past year, the German government has been working on legislation to implement the EU’s General Data Protection Regulation (GDPR). On July 6, 2017, Germany did so by passing a statute titled the Data Protection Amendments and Implementation Act. The Act repeals Germany’s venerated Federal Data Protection Act (Bundesdatenschutzgesetz, or BDSG) and replaces it with an entirely new BDSG, aptly referred to as the “BDSG-New.” Germany becomes the first EU Member State to pass a GDPR implementation statute. Given Germany’s reputation as one of, if not the, most serious privacy jurisdiction [...] Read more
Health insurance giant Anthem, Inc. agreed to the largest data breach settlement to-date last week, ending multi-district consumer litigation over a 2015 data breach for $115 million. The data breach, which resulted from a hacker-orchestrated cyberattack following the theft of an employee password, exposed personally identifiable information (“PII”) and protected health information (“PHI”) of nearly 80 million people. The stolen information included the names of current and former clients, dates of birth, addresses, social security numbers, and other medical information.
The settlement [...] Read more
On August 4, 2016, the Office of Civil Rights (“OCR”) announced that Advocate Health Care Network (“Advocate”), Illinois’ largest fully-integrated health care system, has agreed to pay a record-breaking $5.55 million to settle claims of multiple Health Insurance Portability and Accountability Act (“HIPAA”) violations involving electronic protected health information (“ePHI”). The substantial settlement stems from the extent and duration of the alleged noncompliance and the large number of individuals whose information was compromised, among other factors.
The OCR initiated [...] Read more
Today, the U.S. Department of Health & Human Services’s (HHS) Office for Civil Rights (OCR) announced the launch of Phase 2 of its HIPAA Compliance Audit Program. (OCR’s announcement can be accessed at Audit Phase 2 Announcement and further information about Phase 2 can be accessed at Audit Phase 2 Information.) In this phase, OCR will review the policies and procedures that covered entities and business associates have adopted and implemented to meet certain standards and implementation specifications of the HIPAA Privacy, Security, and/or Breach Notification Rules. Phase 2 will consist [...] Read more
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