United States: SAMHSA Proposes Major Changes To Federal Substance Abuse Privacy Rule

Almost thirty years after the last substantive change to the federal regulations governing the confidentiality of alcohol and drug abuse patient records, the Substance Abuse and Mental Health Services Administration (SAMHSA) today published a proposed rule (Proposed Rule) to modernize the regulations at 42 CFR Part 2 (the Part 2 Rule). Public comment period on the Proposed Rule is open until April 11, 2016.

In recognition of the significant changes that have occurred within the United States health care system, SAMHSA proposes to update the regulations to facilitate the electronic exchange of substance use disorder information for treatment and other legitimate health care purposes — without compromising the key role of the regulations in protecting patient privacy. Federal officials are concerned that the Part 2 Rule makes it difficult for patients whose health records contain substance abuse treatment data to receive care from providers participating in alternative payment models, because these models emphasize coordinating patient care with other providers and analyzing patient records for insight into quality improvement. The Proposed Rule is intended to ensure that patients with substance use disorders have the ability to participate in new integrated health care models like accountable care organizations and health homes without fear that sensitive information will be used against them.

Under the Proposed Rule, significant changes would be made to the consent requirements to allow patients to authorize disclosures to entities like health information exchange organizations (HIEs). In addition, SAMHSA proposes several key clarifications: (1) that population health activities are among the scope of activities that can be conducted by a qualified service organization (QSO), (2) that the Part 2 requirements do not apply to general medical practices, and (3) that the prohibition on re-disclosure only applies to information that would identify, directly or indirectly, an individual as having been diagnosed, treated, or referred for treatment for a substance use disorder. Other updates have also been proposed to provide more discretion for providers to determine when a "medical emergency" exists, address electronic records (such as clarification that e-signatures are sufficient for consent forms), and liberalize the requirements for research disclosures.

Consent Requirements

Currently, the Part 2 Rule requires written patient consent for most disclosures of patient substance abuse records. The consent must specify the name or title of each individual or the name of each organization to which disclosure is to be made. In a significant departure from the current approach, however, the Proposed Rule would allow the consent form to identify as recipients an entity like a health information exchange organization or a research institution and to generally designate providers with a treating provider relationship with the patient. For example, the proposed change would allow a patient consent form to designate as authorized recipients a named HIE and "my treating providers." The Proposed Rule notes that such a general designation would require the HIE to have a mechanism in place to determine whether a treating provider relationship existed with the patient, such as a method for patients to designate treating providers through a patient portal. Additionally, the Proposed Rule would require that the HIE provide patients who have consented to disclose their information using a general designation, upon their request, with a list of entities to which their information had been disclosed within the last two years pursuant to the general designation. The requirement to provide such an accounting would not take effect until two years after the effective date of the final rule. In addition, SAMHSA proposes to allow electronic signatures, to the extent permissible under applicable law.

Qualified Services Organizations

The current Part 2 Rule authorizes disclosure without patient consent to QSOs that provide services to a Part 2 program if certain requirements are met. The Proposed Rule would clarify that population health management is one of the types of services that may be offered by a QSO. According to the preamble, a Part 2 program could disclose information under a properly executed QSO agreement to the office or unit responsible for population health management in an organization like an ACO, health home, or managed care organization. However, the preamble also clarifies that care coordination was deliberately not added to the list of examples of QSO services in the Proposed Rule because it includes a patient treatment component, which is not an appropriate reason to disclose information to a QSO.

Application of Regulations to General Medical Practices

SAMHSA is proposing changes to the "Program" definition. In recognition of the fact that more substance use disorder treatment services are occurring in general health care and integrated care settings, the Proposed Rule would clarify that the definition of "Program" would not apply to "general medical facilities" and "general medical practices," unless an identified unit within a general medical facility or general medical practice holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment, or if the primary function of medical personnel or other staff in the general medical facility or general medical practice is the provision of such services and they are identified as providing such services. Further, the Proposed Rule adds a definition of "holds itself out" to mean any activity that would lead one to reasonably conclude that the individual or entity provides substance use disorder diagnosis, treatment, or referral for treatment, including but not limited to:

  • Authorization by the state or federal government (e.g. licensure, certification, or registration) to provide such services;
  • Advertisements, notices, or statements related to such services; or
  • Consultation activities relative to such services.

Prohibitions on Re-disclosure

SAMHSA proposes to clarify that the Part 2 prohibition on re-disclosure only applies to information that would identify, directly or indirectly, an individual as having been diagnosed, treated, or referred for treatment for a substance use disorder, and could allow re-disclosure of other health-related information disclosed by a Part 2 program. For example, if an individual receives substance use disorder treatment from a Part 2 program and also receives treatment for a health condition such as high blood pressure, Part 2 does not prohibit re-disclosure of the information related to the high blood pressure.

However, certain medical information may reveal that an individual has a substance abuse disorder, such as illnesses that are brought about by drug or alcohol abuse or prescriptions for a medication used for substance use disorder treatment. In addition, if the origin of the data (such as a treatment clinic) would reveal that the individual has a substance abuse disorder, then the disclosure would be prohibited.

Medical Emergency

The Proposed Rule would align the definition of "medical emergency" with the statutory definition. The revised language would permit patient identifying information to be disclosed to medical personnel to the extent necessary to meet a bona fide medical emergency, in which the patient's prior informed consent cannot be obtained.

Electronic Records

The Proposed Rule would incorporate electronic records in the security requirements under Part 2. The Proposed Rule would establish procedures for sanitizing electronic media for handling electronic records subsequent to the discontinuation of a Part 2 program. Similarly, the Proposed Rule would include electronic records in the exception for disclosure without consent for audit and evaluation activities.

Research Disclosures

The current Part 2 Rule allows patient information to be disclosed without consent for the purpose of conducting scientific research if the program director makes a determination that specified requirements have been met. The Proposed Rule would liberalize the research exception by allowing any individual in lawful possession of Part 2 data to disclose the information to qualified research personnel for the purpose of conducting scientific research if applicable requirements were satisfied, including privacy regulations under HIPAA and regulations for the protection of human subjects under the Common Rule. The Proposed Rule would also address data linkages to enable researchers holding Part 2 data to link to federal data sets.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions