Solara Medical Supplies, LLC

Today the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Solara Medical Supplies, LLC (Solara), a supplier and direct-to-patient distributor of continuous glucose monitors, insulin pumps, and other supplies to patients with diabetes, concerning potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule and Breach Notification Rule following a breach of electronic protected health information (ePHI) caused by a phishing incident. 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, and security of electronic PHI. The HIPAA Breach Notification Rule requires covered entities to notify affected individuals, HHS, and, in some cases, the media, following the discovery of a breach of unsecured PHI. Business associates are also required to notify covered entities following the discovery of a breach. The settlement resolves an investigation concerning a phishing attack on Solara’ s information system. In November 2019, OCR received a breach report concerning a phishing attack in which an unauthorized third party gained access to eight of Solara’s employees’ email accounts between April and June 2019, resulting in the breach of 114,007 individuals’ ePHI. In January 2020, OCR received notification of a second breach, when Solara reported that it had sent 1,531 breach notification letters to the wrong mailing addresses. OCR’s investigation determined that Solara failed to conduct a compliant risk analysis to identify the potential risks and vulnerabilities to ePHI in Solara's systems; failed to implement security measures sufficient to reduce the risks and vulnerabilities to ePHI to a reasonable and appropriate level; and failed to provide timely breach notification to individuals, HHS, and the media. Under the terms of the resolution agreement, Solara agreed to implement a corrective action plan that will be monitored by OCR for two years and pay $3,000,000 to OCR. Under the corrective action plan, Solara will be required to take definitive steps to resolve potential violations of the HIPAA Security and Breach Notification Rules. The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/solara-ra-cap/index.html