Privacy guidelines to enhance coordination of care, keep away from discrimination in remedy.
The U.S. Department of Health and Human Services (HHS) announced proposed changes to the Confidentiality of Substance Use Disorder (SUD) Patient Records below 42 CFR half 2 (Part 2). The federal guidelines shield affected person privateness and data regarding remedy associated to substance use challenges from unauthorized disclosures, in keeping with HHS.
The rule will increase coordination amongst suppliers of remedy for substance use challenges whereas including protections for sufferers regarding data disclosure to keep away from discrimination.
“Varying requirements of privacy laws can slow treatment, inhibit care, and perpetuate negative stereotypes about people facing substance use challenges,” HHS Secretary Xavier Becerra mentioned in a information launch. “This proposed rule would improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure.”
The Notice of Proposed Rulemaking (NPRM) is scheduled to be revealed Dec. 2 within the Federal Register, which is able to open a 60-day public remark interval. HHS has posted a replica of the discover on-line, with an online fact sheet, and feedback could also be submitted via regulations.gov.
HHS is publishing the NPRM via the Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA).
The new guidelines comply with years of physicians, sufferers, households, and society generally reeling from crisis levels of opioid addiction and overdose. This month, the U.S. Centers for Disease Control and Prevention updated the guidelines for physicians contemplating prescribing opioids for sufferers’ ache aid.
Align with HIPAA
The new rule would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that require HHS to convey Part 2 into higher alignment with sure points of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Breach Notification, and Enforcement Rules, in keeping with HHS.
Proposed modifications embrace:
- Permitted use and disclosure of Part 2 data based mostly on a single affected person consent given as soon as for all future makes use of and disclosures for remedy, cost, and well being care operations.
- Permitted redisclosure of Part 2 data in any method permitted by the HIPAA Privacy Rule, with sure exceptions.
- New affected person rights below Part 2 to acquire an accounting of disclosures and to request restrictions on sure disclosures, as additionally granted by the HIPAA Privacy Rule.
- Expanded prohibitions on the use and disclosure of Part 2 data in civil, felony, administrative, and legislative proceedings.
- New HHS enforcement authority, together with the imposition of civil cash penalties for violations of Part 2.
- Updated breach notification necessities to HHS and affected sufferers.
- Updated HIPAA Privacy Rule Notice of Privacy Practices necessities to handle makes use of and disclosures of Part 2 data and particular person rights with respect to these data.
Part 2 presently imposes completely different necessities for SUD remedy data protected by Part 2 than the HIPAA Privacy Rule. That can create obstacles to data sharing by sufferers and amongst well being care suppliers and create twin obligations and compliance challenges for regulated entities, in keeping with HHS.
The federal division understands it’s essential for sufferers to higher align the Part 2 guidelines and program with HIPAA, OCR Director Melanie Fontes Rainer mentioned within the information launch.
“This proposed rule helps decrease burdens on patients and providers, improves coordination and increases access to care and treatment, while protecting confidentiality of treatment records,” Rainer mentioned.
SAMHSA has a precedence to make efficient therapies and restoration helps for SUD extra accessible to all who want them, SAMHSA chief Miriam E. Delphin-Rittmon, PhD, mentioned within the information launch. Delphin-Rittmon is also HHS Assistant Secretary for Mental Health and Substance Use.
“Bringing Part 2 requirements into closer alignment with HIPAA will support more effective coordination for people accessing care,” Delphin-Rittmon mentioned. “At the same time, the proposed rule mitigates the discrimination and stigma that we know too often people with SUDs experience.”