Regional Women's Health Group, LLC d/b/a Sincera Reproductive Medicine: 37,989 individuals, Dec 2020.

Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced settlements with four regulated entities following separate ransomware investigations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. Ransomware is malicious software that blocks access to data-typically by encrypting it with a key known only to the attacker-until a ransom is paid. The resolutions announced mark 19 completed investigations from ransomware breaches and 13 completed investigations in OCR's Risk Analysis Initiative.

OCR enforces the HIPAA Privacy, Security, and Breach Notification Rules, which set forth the requirements that covered entities (health plans, health care clearinghouses, and most health care providers), and business associates must follow to protect the privacy and security of protected health information (PHI). The HIPAA Security Rule establishes national standards to protect and secure our health care system by requiring administrative, physical, and technical safeguards to ensure the confidentiality, integrity, security, and availability of electronic PHI (ePHI). The Risk Analysis provision requires regulated organizations (covered entities and business associates) to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by those organizations.

The settlements follow investigations into separate ransomware breaches that collectively affected over 427,000 individuals and involved the exposure of unsecured ePHI. The types of ePHI affected include demographic data, Social Security numbers (SSNs), financial information, lab results, medications, and diagnoses or conditions. Under the settlements, the regulated entities have agreed to implement corrective action plans subject to OCR monitoring for two years and paid a total of $1,165,000 to OCR.

Today's announcement covers settlements with the following regulated entities.

• Regional Women's Health Group, LLC ("RWHG"), doing business as Axia Women's Health, is a network of women's health care providers in New Jersey, Pennsylvania, Ohio, Indiana, and Kentucky. The ransomware breach affected 37,989 individuals. The types of ePHI affected by the breach included names, addresses, dates of birth, SSNs, driver's license numbers, diagnoses or conditions, lab results, and medications. RWHG reported in December 2020 that an unauthorized third-party gained access to its IT network and potentially exfiltrated data from RWHG's electronic medical record database housing patient ePHI. OCR's investigation found that RWHG failed to conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of its ePHI. In addition to committing to corrective actions, RWHG paid $320,000 to OCR.