HIPAA

Subscribe to HIPAA via RSS

On January 21, 2021, the Department of Health and Human Services (HHS) published proposed modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), discussed in a previous McGuireWoods’ post. The comment period for these proposals recently ended on May 6, 2021, and HHS received almost 1500 comments from interested stakeholders. If finalized, these proposals will require HIPAA-covered entities and business associates to implement many changes, including updates to their policies, procedures, security standards, notices of privacy practices, authorization and disclosure forms, and business associate agreements. In the age of digital targeting and ransomware, possibly the most important of these is a change to security standards.
Continue Reading As HIPAA, HITECH Undergo Modernization, NIST Seeks Comment on Security Standard Guidance

As we discussed in Part I, the United States does not have a single, comprehensive federal law governing biometric data.  However, we have recently seen an increasing number of states focusing on this issue.  Part I summarized legislative activity on this issue in 2020.  In this Part II, we discuss noteworthy legislation to monitor in 2021.

What to Expect in 2021

At least two states—New York and Maryland—have already introduced biometrics legislation in this first month of 2021.

New York – AB 27

On January 6, 2021, the New York Assembly introduced the Biometric Privacy Act (BPA), a New York state biometric law aimed at regulating businesses handling biometric data.  BPA will prohibit businesses from collecting biometric identifiers or information without first receiving informed consent from the individual, prohibit profiting from the data, and will require a publicly available written retention and destruction policy.  As proposed, the statute contains a private right of action; and if passed, it will permit consumers to sue businesses for improperly collecting and using their biometric data.  The statute follows Illinois’s BIPA, allowing recovery of $1,000 per negligent violation and $5,000 per intentional violation, or actual damages, whichever is greater, along with attorney’s fees and costs, and injunctive relief.Continue Reading U.S. Biometrics Laws Part II: What to Expect in 2021

On January 21, 2021, the Department of Health and Human Services (HHS) published proposed modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH).

The proposed rule is part of HHS’ Regulatory Sprint to Coordinated Care, which seeks to promote value-based healthcare by examining federal regulations that impede efforts among healthcare providers and health plans to better coordinate care for patients. Specifically, HHS aims to amend the regulations implemented pursuant to HIPAA and HITECH where the rules present barriers to coordinated care and case management or where they otherwise impose burdens on covered entities that do not increase individuals’ privacy protections.Continue Reading Department of Health and Human Services Announces Proposed Changes to the HIPAA Privacy Rule

Healthcare providers and other covered entities are not required by HIPAA regulations to have “bulletproof” protections for safeguarding patient information stored in electronic form, according to a January 14, 2021 decision of the 5th U.S. Circuit Court of Appeals. In University of Texas M.D. Anderson v. U.S. Department of Health and Human Services, the 5th Circuit vacated a $4.3 million civil monetary penalty imposed by the U.S. Department of Health and Human Services (HHS) against the University of Texas’ M.D. Anderson Cancer Center.

The case arises from three separate incidents where M.D. Anderson employees lost laptops and USB thumb drives that contained unencrypted protected health information (PHI) for more than 34,000 patients. M.D. Anderson reported the breach incidents to HHS’ Office for Civil Rights (OCR), the office tasked with enforcing HIPAA. As a result of the reported breaches, OCR ordered M.D. Anderson to pay $4.3 million in civil monetary penalties (CMPs). M.D. Anderson appealed the decision to an HHS administrative law judge and to the HHS Departmental Appeals Board (DAB), both of which upheld OCR’s penalties. M.D. Anderson argued that the HIPAA regulations do not require encryption, that it complied with the regulations and employed other effective measures to safeguard electronic protected health information (ePHI), that the three incidents were the fault of staff who violated M.D. Anderson’s policies, and that the proposed CMPs were excessive.Continue Reading 5th Circuit Weakens HHS’ Ability to Enforce HIPAA Safeguards

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) reached a settlement for $1,500,000 and entered into a substantial corrective action plan with Athens Orthopedic Clinic (AOC) as a result of AOC’s alleged systemic noncompliance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. AOC, located in Georgia, provides a wide range of orthopedic services to approximately 138,000 patients a year.

Problems began for AOC in June 2016, when the practice was notified by a journalist that AOC patient records may have been posted for sale on the internet. Shortly thereafter, AOC was contacted by a hacker demanding payment for the stolen patient records. It was later determined that the hacker had accessed AOC’s electronic medical records using a vendor’s credentials on June 14, 2016, and continued to access protected health information (PHI) until July 16, 2016. AOC filed a breach report with OCR on July 29, 2016, revealing that the names, dates of birth, social security numbers, and other PHI of over 200,000 patients had been compromised by this breach.Continue Reading Hacked Patient Records Land Athens Orthopedic Clinic in Hot Water with OCR

Since the outbreak of COVID-19, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has issued various notifications of enforcement discretion related to compliance with the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, discussed previously. However, OCR issued guidance on May 5, 2020, reminding covered healthcare providers that the HIPAA Privacy Rule remains in force during the COVID-19 public health crisis except as expressly relaxed under OCR’s prior guidance. Specifically, OCR’s most recent guidance addresses the disclosure of patient protected health information (PHI) to the media by allowing the media to film patients in facilities where PHI is accessible.
Continue Reading OCR Warns Providers and Media: Patient Privacy Remains Protected Despite Pandemic

Since the outbreak of COVID-19, the Department of Health and Human Services Office for Civil Rights (OCR) has issued various guidance documents on compliance with the Health Insurance Portability and Accountability Act of 1996 and its regulations. The topics include OCR’s discretion in enforcing HIPAA with respect to telehealth services, waiving hospital compliance with the HIPAA Privacy Rule in limited circumstances, and Privacy Rule compliance in the absence of specific waiver. The OCR guidance, discussed below, confirms that HIPAA still applies during the pandemic but compliance may be relaxed in certain situations to allow healthcare providers to respond effectively to the current public health emergency.
Continue Reading HHS Limited Waiver and Guidance on HIPAA and the Privacy Rule During COVID-19 Pandemic

In the first published enforcement action of 2020, a gastroenterology practice in Ogden, Utah, has agreed to pay a $100,000 settlement to the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) for alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”) Security Rule.

According to the Resolution Agreement entered into between Steven A Porter, M.D., P.C. (the “Practice”) and OCR, the Practice reported a breach to OCR in 2013 due to conduct by a business associate of the Practice. While investigating the breach, OCR determined that the Practice had not implemented appropriate policies and procedures to address security violations, failed to conduct a security risk analysis, and did not have reasonable and appropriate security measures in place. Further, the Practice had used an electronic health records vendor for several years without entering into an appropriate business associate agreement.

In addition to the $100,000 payment, the Practice is required to submit to a Corrective Action Plan for a two-year period. The Corrective Action Plan requires the Practice to take a series of broad measures in furtherance of HIPAA compliance, detailed below.
Continue Reading Small Businesses Are Not Safe from Big HIPAA Liability

A recent letter from researchers at the Mayo Clinic to the editor of The New England Journal of Medicine outlined a new challenge in de-identifying, or preserving the de-identified nature of, research and medical records.[1]  The Mayo Clinic researchers described their successful use of commercially available facial recognition software to match the digitally reconstructed images of research subjects’ faces from cranial magnetic resonance imaging (“MRI”) scans with photographs of the subjects.[2]  MRI scans, often considered non-identifiable once metadata (e.g., names and other scan identifiers) are removed, are frequently made publicly available in published studies and databases.  For example, administrators of a national study called the Alzheimer’s Disease Neuroimaging Initiative estimate other researchers have downloaded millions of MRI scans collected in connection with their study.[3]  The Mayo Clinic researchers assert that the digitally reconstructed facial images, paired with individuals’ photographs, could allow the linkage of other private information associated with the scans (e.g., cognitive scores, genetic data, biomarkers, other imaging results and participation in certain studies or trials) to these now-identifiable individuals.[4]
Continue Reading Technology Continues to Outflank Health Information Anonymization

In one of this year’s largest HIPAA settlements, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) is set to collect $3 million from the University of Rochester Medical Center (URMC). This settlement over potential violations of the Privacy and Security Rules under HIPAA also requires URMC to follow a corrective action plan that includes two years of HIPAA compliance monitoring by OCR.
Continue Reading Unencrypted Mobile Devices Cost Medical Center $3 Million In HIPAA Settlement