Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted, supported, or regulated by the federal government. While many of the Common Rule changes go into effect in 2018, the single IRB … Continue Reading
April proved to be a busy month for the U.S. Department of Health and Human Services Office for Civil Rights (OCR) under its newly appointed director, Roger Severino. OCR announced three settlements of potential HIPAA violations totaling nearly $3,000,000.00 in fines. The settling parties include a wireless health services provider, a federally-qualified health center (FQHC), and … Continue Reading
Children’s Medical Center of Dallas (Children’s) was hit with a $3.2 million civil penalty from the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) for failing to take steps to properly protect patient medical information. The civil penalty is the result of two data breaches caused by a lack of encryption … Continue Reading
As the East Coast prepares for the arrival of Hurricane Matthew, covered entities and business associates should take the opportunity to remind their workforce members to safeguard protected health information (PHI) that is in paper form. Certainly, HIPAA requires covered entities and business associates to protect and secure PHI at all times. However, healthcare providers that … Continue Reading
The Department of Health and Human Services Office for Civil Rights (OCR) announced on August 4, 2016, a settlement agreement with Advocate Health Care Network, an integrated healthcare system with ten hospitals and a non-profit medical group of more than 1,500 physicians in Illinois (the System or Advocate). The System agreed to adopt a corrective … Continue Reading
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released its much-anticipated guidance on ransomware (OCR Ransomware Guidance) this week in response to a number of highly publicized attacks targeting the healthcare sector. Ransomware is a type of malicious software that encrypts data, making it inaccessible until the data owner … Continue Reading
Last week, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced the first HIPAA settlement involving a business associate. Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS), a nonprofit organization that provides management and information technology services to six wholly-owned skilled nursing facilities, agreed to pay $650,000 and enter … Continue Reading
A New York hospital has settled with the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) for $2.2 million after allowing a TV crew for the ABC documentary series “NY Med” to film patients receiving medical treatment without obtaining prior authorization from the patients or their representatives. The estate of one … Continue Reading
A group practice that was the victim of a silver-harvesting scam has agreed to pay the U.S. Department of Health and Human Services (“HHS”) $750,000 to settle charges that it released protected health information (“PHI”) of its patients to a third party vendor without first obtaining a written business associate agreement. Raleigh Orthopaedic Clinic, P.A. … Continue Reading
Just in time for the Phase 2 audits, the Department of Health and Human Services Office for Civil Rights (OCR) quietly posted the updated HIPAA Audit Protocol on its website. The new audit protocol has been updated to include business associates who became subject to HIPAA following the 2013 HIPAA Omnibus Final Rule. The protocol … Continue Reading
The U.S. Department of Health and Human Services Office of Civil Rights (OCR) recently announced that it has started obtaining and verifying entity contact information to identify covered entities and business associates for potential audit subject pools for the 2016 Phase 2 HIPAA Audit Program. In Phase 2, OCR will review the policies and procedures … Continue Reading
On February 25, 2016, the Office of Civil Rights (OCR) released a set of FAQs directed at healthcare providers and plans that are required to comply with the HIPAA Privacy Rule (the Privacy Rule). The guidance emphasizes that any fees charged for access to or copies of patient information must be “reasonable and cost-based” and … Continue Reading
An Illinois circuit court judge has dismissed five of six claims in a consolidated class action against Advocate Health and Hospital Corporation arising from a data breach in July 2013. The judge’s dismissal with prejudice leaves only a negligence claim, based on a duty to reasonably safeguard information, pending against Advocate.… Continue Reading
On June 2, 2015, the Second District Illinois Appellate Court affirmed the decisions of two lower courts, which had dismissed breach of privacy cases for lack of standing. The cases were consolidated for the purposes of the appeal. Both cases were brought against Advocate Health and Hospitals Corporation d/b/a Advocate Medical Group (Advocate), an Illinois … Continue Reading
On Monday, January 26, 2015, the Department of Health and Human Services (“HHS”) announced a timeline for moving physicians and hospitals into new payment systems and tying Medicare reimbursements to quality of care. This will affect hundreds of billions of dollars in Medicare payments (the goals apply to Medicare Parts A and B, which paid … Continue Reading
On December 17, 2014, the Centers for Medicare and Medicaid Services (“CMS”) announced that there would be reductions in Medicare reimbursement for health care providers who do not meet the CMS electronic health record (“EHR”) incentive program’s meaningful use requirements. This announcement comes in the wake of CMS’ decision in October to extend the hardship … Continue Reading
Social media can be an effective and easy way to connect with friends and professional contacts. However, it can also serve as a tool for institutions and principal investigators involved in enrolling subjects in clinical research to connect with prospective patients and subjects for clinical trial recruitment. The research shows that, to-date, there has not … Continue Reading
The Affordable Care Act contains a provision known as the Physician Payments Sunshine Act, which requires the Centers for Medicare and Medicaid Services (CMS) to establish a national databank containing information on the financial relationships between physicians (which includes dentists, chiropractors, and other physician specialties) and teaching hospitals, applicable manufacturers, and group purchasing organizations (GPOs). … Continue Reading
On July 10, 2014, a Kane County, Illinois Circuit Court granted a motion to dismiss with prejudice in favor of Advocate Health & Hospitals Corporation (Advocate) in a class action case arising out of a breach of patients’ protected health information (PHI). In August 2013, Advocate reported one of the largest data breaches to date … Continue Reading
