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

On March 9, the Department of Health and Human Services announced it was extending until May 6, 2021, the comment period for proposed changes to regulations implementing the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act of 2009.

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2021 is shaping up to be a groundbreaking year for employment litigation topics, and Illinois’ Biometric Information Privacy Act (BIPA) is no exception. State and federal appellate courts in Illinois are poised to decide several open issues, including the proper limitations period, whether the Workers Compensation Act pre-empts BIPA claims and whether BIPA liquidated damages

Under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and specifically the Privacy Rule under HIPAA’s implementing regulations, patients have a right to access their health information held by health care providers. In 2016, the Department of Health and Human Services’ Office for Civil Rights (OCR) issued guidance stressing the importance of this right. The OCR also implemented a HIPAA Right of Access Initiative as an enforcement priority in 2019, and the OCR has since actively pursued violations under the right of access standard.

Continue Reading OCR Continues to Crack Down on Right of Access Violations

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

On November 4, 2020, the Office of the National Coordinator for Health Information Technology (ONC) published an Interim Final Rule with Comment Period (IFC) that delays compliance dates necessary to meet certain requirements related to information blocking initially finalized in the ONC Cures Act Final Rule (Final Rule) in March of 2020. The Final Rule implemented health IT provisions enacted under the 21st Century Cures Act (the Cures Act) to achieve ubiquitous interoperability among health IT systems and to improve patient’s ability to access their electronic health information (EHI). Among these provisions is a prohibition of information blocking. This article will define information blocking, provide and explain exceptions to such practice, detail the IFC’s deadline extensions, and highlight key compliance concerns and solutions regarding these reforms.

Information Blocking

The term “Information Blocking” is broadly defined by the Cures Act as any practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of EHI when the entity knows (or should know) that it is likely to do so. The Cures Act specifies four types of “actors” that must comply with the information blocking rule:

  1. Healthcare Providers
  2. Health information technology companies that have a certified health IT system
  3. Health information networks (HINs)
  4. Health information exchanges (HIEs)


Continue Reading Information Blocking Compliance: What Providers Need To Know As Deadlines Approach

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