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Enhancing Privacy Protections for Substance Use Disorder Patient Records

Client Alert
February 16, 2024

On February 8, 2024, the U.S. Department of Health and Human Services (“HHS”) finalized updated rules to 42 CFR Part 2 (“Part 2”) for the protection of Substance Use Disorder (“SUD”) patient records. The updated rules reflect the requirement that the Part 2 rules be more closely aligned with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) privacy, breach notification, and enforcement rules as mandated by the Coronavirus Aid, Relief, and Economic Security Act of 2020.

Part 2 protects the SUD treatment records of patients who are treated at a Part 2 program. Part 2 programs are those that are (1) federally assisted (they receive federal funding) and (2) hold themselves out as providing, and do provide, substance use disorder diagnosis, treatment, or referral for treatment. The final rules released by HHS this month reflect the inclusion of the public comments from providers, trade associations, health information exchanges, health plans and others.

The final rules make the following modifications to Part 2 regulations, effective February 16, 2026:

  • Patient Consent: One single Part 2 consent will be sufficient for all future disclosures for payment, treatment, and health care operations. All disclosures made with patient consent must include a copy of the consent or a clear explanation of the scope of consent. Previously, a separate consent was needed for each disclosure of Part 2 information. However, the final rules do retain a prohibition on the use of Part 2 records in legal proceedings and testimony in civil, criminal, administrative, and legislative proceedings against a patient without specific consent or a court order.
  • Counseling Notes: Like HIPAA psychotherapy records, a separate patient consent for the use and disclosure of SUD counseling notes is now required. SUD counseling notes include those analyzing the conversation in a SUD counseling session that the clinician voluntarily maintains separately from the rest of the patient’s SUD treatment and medical record.
  • Patient Notice: Part 2 patient notice requirements now align with the requirements of the HIPAA Notice of Privacy Practices.
  • Redisclosure: HIPAA covered entities and business associates that receive records under a Part 2 consent may redisclose those records according to HIPAA regulations. Previously, Part 2 regulations required a specific disclosure that was stricter than HIPAA redisclosure regulations.
  • Public Health: Part 2 records may now be disclosed to public health authorities without patient consent as long as the records are de-identified.
  • Breach Notification: The HIPAA Breach Notification Rule requirements will also apply to breaches of records under Part 2.
  • Segregation of Part 2 Data: Part 2 records are no longer required to be segregated or segmented from other medical records.
  • Fundraising: Patients will be able to opt out of receiving fundraising communications from Part 2 programs.
  • Complaints: Patients will have a right to file a complaint directly with the Secretary of HHS for an alleged violation of Part 2 in addition to filing a complaint with the Part 2 program.
  • Penalties: Part 2 penalties will be aligned with HIPAA by replacing criminal penalties currently in Part 2 with civil and criminal enforcement authorities that also apply to HIPAA violations.

The text of the final rule can be found on the Federal Register. All Part 2 programs must comply with the new requirements by February 16, 2026. The BMD healthcare team can help ensure that you are compliant. Please reach out to Daphne Kackloudis (dlkackloudis@bmdllc.com) or Jordan Burdick (jaburdick@bmdllc.com) for questions or assistance.

Health LawHealthcare Policysubstance abuseDaphne KackloudisJordan Burdick
Client Alert

Employer Liability for COVID-19 Vaccine Side Effects

June 9, 2021As employers encourage or require employees to obtain a COVID-19 vaccine, they should be aware of OSHA recording obligations and potential workers’ compensation liability. Though OSHA has yet to revise its COVID-19 guidance in response to the latest CDC recommendations, OSHA has revised its position regarding the recording of injury or illness resulting from the vaccine. Until now, OSHA required an employer to record an adverse reaction when the vaccine was required for employees and the injury or illness otherwise met the recording criteria (work-related, a new case, and meets one or more of the general recording criteria). OSHA has reversed course and announced that it will not require recording adverse reactions until at least May 2022, irrespective of whether the employer requires the vaccine as a condition of employment. In its revised COVID-19 FAQs, OSHA states:Client Alert

The New Rule 1.510 - Radical Change for Summary Judgement Procedure in Florida

June 8, 2021In civil litigation, where both sides participate actively, trial is usually required at the end of a long, expensive case to determine a winner and a loser. In federal and most state courts, however, there are a few procedural shortcuts by which parties can seek to prevail in advance of trial, saving time, money and annoyance. The most common of these is the “motion for summary judgment”: a request to the court by one side for judgment before trial, generally on the basis that the evidence available reflects that a win for that party is legally inevitable and thus required. Effective May 1, 2021, summary judgment procedure in Florida has radically changed.Client Alert

Vacating, Modifying or Correcting an Arbitration Award Under R.C. 2711.13: Three-Month Limitation Maximum; Not Guaranteed Amount of Time

June 8, 2021In a recent decision, the Supreme Court of Ohio held that neither R.C. 2711.09 nor R.C. 2711.13 requires a court to wait three months after an arbitration award is issued before confirming the award. R.C. 2711.13 provides that “after an award in an arbitration proceeding is made, any party to the arbitration may file a motion in the court of common pleas for an order vacating, modifying, or correcting the award.” Any such motion to vacate, modify, or correct an award “must be served upon the adverse party or his attorney within three months after the award is delivered to the parties in interest.” In BST Ohio Corporation et al. v. Wolgang, the Court held the three-month period set forth in R.C. 2711.13 is not a guaranteed time period in which to file a motion to vacate, modify, or correct an arbitration award. 2021-Ohio-1785.Client Alert

EEOC Provides Updated Guidance Regarding Employer COVID-19 Vaccine Policies

June 3, 2021On May 28, 2021, the U.S. Equal Employment Opportunity Commission updated its guidance regarding employer COVID-19 vaccination policies. The new guidance provides much-needed clarification of expectations for employers seeking to promote workplace safety and prevent the spread of COVID-19, including discussion of mandatory vaccination policies, voluntary vaccination incentives, and accommodation of employees based on disability or sincerely held religious beliefs. The full text of the update is found in Section K of the EEOC’s COVID Q&A document. You can also learn more about these and other developments from BMD's Bryan Meek and Monica Andress through the Employment Law After Hours YouTube channel, available here.Client Alert

What Telemedical Barriers Practices Face and How They Can Manage Them

May 28, 2021The onset of the COVID-19 pandemic has led to many businesses and industries having to rapidly adapt new practices in order to stay profitable, and the healthcare industry is no exception. Although telehealth tools and practices have existed and been used since the Vietnam War, the pandemic has caused many individual healthcare practices to heavily rely on telehealth as a large portion of their service mix in order to continue to provide care for patients. Because of this rapid adoption of telehealth practices in order to combat the restrictions of COVID-19, the telemedicine industry’s revenue has exploded in the last year. Experts predict that telehealth will continue to grow in use beyond the current pandemic, estimating the industry’s worth to be $25 billion by 2025. However, this rapid adoption of telehealth was prompted out of need and has not been without its own barriers that practices now face.
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