data breach

On January 14, 2021, the United States Court of Appeals for the Fifth Circuit vacated a $4.3 million civil monetary penalty that the Office for Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) imposed against the University of Texas M.D. Anderson Cancer Center (“M.D. Anderson”).  OCR ordered the penalty in 2017 following an investigation into three data breaches suffered by M.D. Anderson in 2012 and 2013, finding that M.D. Anderson had violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information and Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”).  The Court, however, held that the penalty was “arbitrary, capricious, and otherwise unlawful,” in part based on its interpretation of the HIPAA Rules.
Continue Reading M.D. Anderson Wins Appeal Over $4.3 Million HIPAA Penalty

On January 5, 2021, an amendment to the Health Information Technology for Economic and Clinical Health (“HITECH”) Act was signed into law.  The amendment requires the U.S. Department of Health and Human Services (“HHS”) to “consider certain recognized security practices of covered entities and business associates when making certain determinations” regarding fines, audit results, or other remedies for resolving potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  For organizations subject to HIPAA, the amendment provides substantial incentives to establish or improve their cybersecurity programs.  While it does not establish a complete safe harbor from HIPAA enforcement, the amendment does offer organizations a chance to mitigate financial penalties and other negative regulatory actions that may result from a data breach.
Continue Reading HITECH Amendment Provides Some Protection For Covered Entities and Business Associates that Adopt Recognized Security Standards

On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”).  The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes…
Continue Reading FTC to Consider Changes to the Health Breach Notification Rule

At the beginning of August, the D.C. Circuit found that the fact that a data breach has occurred and individual consumer information has been lost may constitute sufficient injury to confer standing on those individual victims at the pleading stage–irrespective of whether any stolen information has been misused. Specifically, Attias, …

Continue Reading Bar to Data Breach Litigation May Be Dropping; Implications for Digital Health Technologies

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently announced a significant settlement with Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS), a business associate under HIPAA, arising from a breach of protected health information (PHI) after the theft of an employee’s iPhone.  The iPhone was not encrypted or password protected and held extensive information on approximately 400 nursing home residents, including Social Security numbers; information regarding diagnosis and treatment, medical procedures, medication; and names of family members and legal guardians.  CHCS agreed to pay financial penalties of $650,000 and adhere to a corrective action plan.
Continue Reading Significant HIPAA Fine Follows Business Associate’s Stolen iPhone

Last week, the chairmen and ranking members of the Senate Committee on Health, Education, Labor, and Pensions and the Senate Committee on Finance sent a letter to Andy Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services (“CMS”), and Jocelyn Samuels, Director of the Health and Human Services (“HHS”) Office for Civil Rights (“OCR”), requesting information on how HHS “is working to support and protect victims of medical identity theft” in order to “assess the adequacy of current efforts.”
Continue Reading Senators Request Information from HHS About Medical Identity Theft Efforts

On December 2, 2014, the Anchorage Community Mental Health Services (ACMHS) agreed to pay $150,000 under a settlement agreement with the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.  ACMHS entered the settlement agreement after an OCR investigation revealed that ACMHS had failed to implement adequate security measures to guard against unauthorized access to electronic protected health information (e-PHI).  The settlement underscores the importance of regularly reviewing and addressing risks to e-PHI.
Continue Reading Recent HIPAA Settlement Highlights Need to Address Software Risks

In its Annual Report to Congress on Breaches of Unsecured Protective Health Information, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) reports on both large and small breaches of protected health information (PHI), as well as breach-related settlement agreements and audits.  The Office also recommends steps that covered entities should take to reduce the likelihood of breaches, including having thorough risk analysis and risk management plans, encrypting PHI stored on portable electronic devices, and ensuring that employees are properly trained on privacy and security policies.
Continue Reading HHS Report Details Breaches of PHI, Makes Recommendations

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently released two annual reports regarding compliance with the Health Insurance Portability and Accountability Act (HIPAA) and provisions enacted by the Health Information Technology for Economic and Clinical Health (HITECH) Act.  The reports indicate that HIPAA-related complaints continue to grow annually; however, OCR intends to focus its compliance efforts on “high-impact” cases unless it obtains additional funding.  Additionally, the reports suggest that OCR is increasingly willing to impose significant penalties and seek large monetary settlements for HIPAA violations.  Below we discuss the Annual Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance, and in a separate post we address the annual report dealing with breaches.
Continue Reading HHS Report Highlights HIPAA Privacy, Security, and Breach Notification Compliance Trends