On May 24, 2017, the China Food and Drug Administration (CFDA) issued its  Circular No. 63 (the Circular), setting out penalties for clinical trial data integrity violations, including intentional data falsification, incomplete and incompliant data and other data defects. The highlights are: (more…)
On Thursday, August 4, 2016, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced that Advocate Health Care Center (Advocate Health) agreed to pay $5.55 million to settle multiple violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This is the largest HIPAA settlement to date against a single entity, and according to OCR, is due to the severity of the HIPAA violations and the length of time that those violations were allowed to persist. OCR alleged that in some instances, the purported violations date back to the effective date of the HIPAA Security Rule.
HHS-OCR has updated its website with guidance on two important and current issues: ongoing HIPAA audits and deidentification. After officially launching phase two of its audit program earlier this month, sending notification letters to 167 covered entities, HHS-OCR has posted updated guidance on its website regarding the audits. Unrelated to the audits, OCR also posted guidance on the treatment of unique device identifiers (UDIs) under HIPAA’s standards for de-identification and limited data sets.
On June 24, 2016, Catholic Health Care Services of the Archdiocese of Philadelphia (“CHCS”) entered into a resolution agreement with the Department of Health and Human Services Office for Civil Rights (“OCR”) to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule after the theft of a CHCS mobile device compromised the protected health information (“PHI”) of 412 nursing home residents. This is OCR’s first settlement with a HIPAA business associate. As part of the settlement, CHCS agreed to enter into a two-year corrective action plan (“CAP”) and pay a monetary penalty of $650,000.
On May 24-25, 2016, the Cybersecurity (EX) Task Force of the National Association of Insurance Commissioners (NAIC) held a two-day interim meeting in Washington, D.C. to discuss the Task Force’s preliminary draft of a model law outlining data security standards applicable to insurance licensees. The Draft Insurance Data Security Model Law (“the Draft Model Law”), first released for public comment on March 2, 2016, would apply to all licensed insurers, producers and other persons licensed or required to be licensed (or authorized or required to be authorized, or registered or required to be registered) pursuant to state insurance laws (“Insurance Licensees”).
On May 17, 2016, the European Council formally adopted the Network and Information Security Directive (the “NIS Directive“) at first reading. According to the Council press release, the NIS Directive is meant to increase cooperation among EU Member States on the vital issues of cybersecurity.
The NIS Directive was first proposed by the European Commission in 2013 as part of the EU’s Cyber Security Strategy. The formal adoption of the NIS Directive by the Council follows on from the political agreement reached in December 2015. It must now be approved by the Parliament at second reading. The NIS Directive is expected to enter into force in August 2016, after which Member States will have 21 months to implement it into their national laws.
On February 3, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that an HHS administrative law judge (ALJ) ordered Lincare, Inc., a home health provider of respiratory care, infusion therapy and medical equipment, to pay $239,800 in civil monetary penalties (CMPs) for violating the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The violations were disclosing patient information to an unauthorized person, failing to take reasonable safeguards to protect patient information from unauthorized disclosure and failing to implement adequate policies and procedures to protect patient information removed from its offices. This marks only the second time that OCR has imposed CMPs for HIPAA violations.
*This post originally appeared in Law360 on January 7, 2016.
While 2015 was a big year in data, 2016 may prove to be even bigger. Many hot button and game changing topics are being debated in legislative bodies and campaign trails, regulators are focused, and privacy-related litigation continues to rise. Below, we count down the top ten cybersecurity, data protection and privacy issues to watch in 2016.
On December 28, 2015, President Obama signed into law S. 2425, the Patient Access and Medicare Protection Act (the “Act”). In addition to provisions intended to ensure that Medicare reimbursement policies promote continued access to certain durable medical equipment, like wheelchair accessories, the Act includes provisions that affect adoption of Health Information Technology (“HIT”) and those that provide greater protection against medical identity theft. Specifically, the Act recognizes various categories of hardship exceptions from meaningful use requirements for the 2015 reporting period and strengthens the penalties associated with medical identity theft.