On January 23, 2019, the European Data Protection Board (“EDPB”) released an opinion on the interplay between the European Clinical Trials Regulation (“CTR”) and the EU General Data Protection Regulation (“GDPR”) (the “Opinion”). The Opinion was requested by the European Commission Directorate-General for Health and Food Safety (“DG SANTE”).

Continue Reading EDPB Releases Opinion on Interplay Between the Clinical Trial Regulation and the GDPR

The U.S. Department of Health and Human Services (“HHS”) recently announced the publication of “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (the “Cybersecurity Practices”). The Cybersecurity Practices were developed by the Healthcare & Public Health Sector Coordinating Councils Public Private Partnership, a group comprised of over 150 cybersecurity and healthcare experts from government and private industry.

Continue Reading HHS Publishes Health Industry Cybersecurity Practices

On October 22, 2018, the Centre for Information Policy Leadership (“CIPL”) at Hunton Andrews Kurth LLP co-hosted a workshop in Brussels on “Can GDPR Work for Health Scientific Research?” (the “Workshop”) with the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) and the Future of Privacy Forum (“FPF”) to address the challenges raised by the EU General Data Protection Regulation (“GDPR”) in conducting scientific health research.

Continue Reading CIPL Co-Hosts Workshop on GDPR and Scientific Health Research

On October 30, 2018, ATA Consulting LLC (doing business as Best Medical Transcription) agreed to a $200,000 settlement with the New Jersey Attorney General resulting from a server misconfiguration that allowed private medical records to be posted publicly online. The fine was suspended to $31,000 based on the company’s financial condition. Read the settlement. Continue Reading Medical Transcription Vendor Agrees to $200,000 Settlement with New Jersey Attorney General

Recently, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement and record settlement of $16 million with Anthem, Inc. (“Anthem”) following Anthem’s 2015 data breach. That breach, affecting approximately 79 million individuals, was the largest breach of protected health information (“PHI”) in history. Continue Reading OCR Enters into Record Settlement with Anthem

On August 15, 2018, U.S. District Judge Lucy Koh signed an order granting final approval of the record $115 million class action settlement agreed to by Anthem Inc. in June 2017. As previously reported, Judge Koh signed an order granting preliminary approval of the settlement in August 2017. Continue Reading Judge Grants Final Approval of Record Data Breach Settlement in Anthem Class Action

In its most recent cybersecurity newsletter, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) provided guidance regarding identifying vulnerabilities and mitigating the associated risks of software used to process electronic protected health information (“ePHI”). The guidance, along with additional resources identified by OCR, are outlined below: Continue Reading OCR Issues Guidance on Disclosures to Family, Friends and Others

On June 6, 2018, the U.S. Court of Appeals for the Eleventh Circuit vacated a 2016 Federal Trade Commission (“FTC”) order compelling LabMD to implement a “comprehensive information security program that is reasonably designed to protect the security, confidentiality, and integrity of personal information collected from or about consumers.” The Eleventh Circuit agreed with LabMD that the FTC order was unenforceable because it did not direct the company to stop any “unfair act or practice” within the meaning of Section 5(a) of the Federal Trade Commission Act (the “FTC Act”). Continue Reading Eleventh Circuit Vacates FTC Data Security Order

The Department of Health and Human Services (“HHS”) recently published two advance notices of proposed rulemaking that address the accounting of disclosures and the potential distribution of civil monetary penalties to affected individuals.

Continue Reading HHS Publishes Advance Notices of Proposed Rulemaking on Accounting of Disclosures and Civil Monetary Penalties