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Kirk Nahra Discusses HIPAA Issues Related to Precision Medicine Security Framework
Kirk J. Nahra, chair of Wiley Rein’s Privacy Practice and co-chair of the Health Care Practice, was quoted in a HealthcareInfoSecurity.com article about the U.S. Department of Health and Human Services’ (HHS) release of a new framework of data security principles related to the Obama Administration’s recently launched Precision Medicine Initiative (PMI). The framework—developed through interagency collaboration among HHS, the Federal Trade Commission, the Veterans Administration, and other agencies and security experts—aims to help health care organizations and researchers participating in PMI to navigate complex privacy and security concerns related to sensitive patient information. According to the article, PMI aims to enroll 1 million volunteers to share their health data and provide a bio-specimen for genetic testing, which HHS acknowledges “warrants careful attention and protection.”
Mr. Nahra pointed out that the “access” provision in the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule “gives individuals a right to a copy of their ‘designated record set,’ which is a HIPAA term that encompasses [all] medical records.”
Mr. Nahra also discussed the security principles that have been issued in connection with the PMI program.
“On the one hand, these principles are a strong overall set of data security principles that will effectively protect data in this context,” Mr. Nahra said. “On the other hand, I’m not sure why they felt the need to have to reinvent the wheel so much, given the existing HIPAA security framework that could easily have been adapted here.”
Mr. Nahra added that he has concerns about the “Utopian approach” that is being taken with the framework principles. “I am not sure these will transfer to less glamourous or more routine [health care] situations, and I am a bit worried that there will be an effort to expand the reach of these principles beyond where they make sense.”
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