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Nationwide Rollup Review of the Centers for Medicare & Medicaid Services Health Insurance Portability and Accountability Act of 1996 Oversight

Our review found that the Centers for Medicare & Medicaid Services' (CMS) oversight and enforcement actions were not sufficient to ensure that covered entities, such as hospitals, effectively implemented the Health Insurance Portability and Accountability Act of 1996 Security Rule. As a result, CMS had limited assurance that controls were in place and operating as intended to protect electronic protected health information (ePHI), thereby leaving ePHI vulnerable to attack and compromise. Both the Social Security Act and the Security Rule require a covered entity, defined as a health plan, health care clearinghouse, or health care provider that transmits any health information in electronic form, to (1) ensure the confidentiality, integrity, and availability of the information; (2) protect against any reasonably anticipated threats or risks to the security or integrity of the information; and (3) protect against unauthorized uses or disclosures of the information.

Our audits of 7 hospitals throughout the Nation identified 151 vulnerabilities in the systems and controls intended to protect ePHI, of which 124 were categorized as high impact. These vulnerabilities placed the confidentiality, integrity, and availability of ePHI at risk. Outsiders or employees at some hospitals could have accessed, and at one hospital did access, systems and beneficiaries' personal data and performed unauthorized acts without the hospitals' knowledge.

We recommended that the Department's Office for Civil Rights (OCR) continue the compliance review process that CMS began in 2009 and implement procedures for conducting compliance reviews to ensure that Security Rule controls are in place and operating as intended to protect ePHI at covered entities. OCR did not comment on our specific findings and stated that it had considered our recommendations. OCR also noted that it maintains a process for initiating covered entity compliance reviews in the absence of complaints and that it had used this process to open compliance reviews as a result of our hospital audits. Although OCR stated that it maintains a process for initiating covered entity compliance reviews in the absence of complaints, it provided no evidence that it had actually done so.

Filed under: Center for Medicare and Medicaid Services