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Background

The Software and Technology Vendors Association (SATVA) is a trade organization for vendors of behavioral health and human services software and information technology. Its members have a genuine concern for promoting the use of effective information technology in behavioral health and human services; helping to formulate and support quality improvement for the highest industry standards; and facilitating the delivery of more efficient and effective consumer services through use of information technology.

Healthcare professionals have traditionally managed ultra-sensitive privacy disclosures using paper consent forms and printed or photocopied patient case records. The process is inefficient but relatively effective with respect to protecting patient confidentiality. Records are traditionally disclosed based on a human judgment of the regulatory environment for the privacy and confidentiality of personally identifiable health information.

Anticipating electronic health information exchange (eHIE), SATVA formed its Behavioral Health (BH) Interoperability Workgroup in 2009. The BH Interoperability Workgroup quickly evolved to emphasize a standards-based concept for managing electronic HIE in full compliance with the regulatory environment for privacy and confidentiality. SATVA focused on 42 CFR Part 2 compliant HIE since meeting restrictive Part 2 regulatory requirements would provide a foundation for meeting other health privacy law regulatory requirements.

The SATVA BH Interoperability Workgroup has sponsored three summits since 2009 with attendees from SAMHSA, the National Council and the Mental Health Corporation of America (MHCA). The National Council and MHCA are behavioral health provider associations and with their assistance these summits identified user requirements for interoperability that focused on the critical need for behavioral health and primary to exchange health information in a standard format and using exchange methods that would function in full compliance with the regulatory environment for privacy and confidentiality.

Federal initiatives promote electronic HIE as a foundational principle for improving healthcare and reducing costs. Electronic HIE presents difficult technology challenges for privacy and confidentiality. A complex regulatory environment magnifies these challenges.

The SATVA solution for electronically exchanging ultra-sensitive privacy disclosures uses a method for ultra-sensitive privacy disclosures developed by SATVA as a pilot project of the Data Segmentation for Privacy (DS4P) work group. Valley Hope Association and Cerner Behavioral Health, two members of the SATVA Interoperability Workgroup, demonstrated the SATVA Ultra-Sensitive Privacy Disclosure (USPD) method for exchanging electronic health information in full compliance with the regulatory environment on September 25, 2013, to the College of Health Information Management Executives (CHIME). The SATVA method demonstrated full patient control over his/her personal health information (PHI). The SATVA method recognizes the regulatory environment imposes obligations on persons or entities disclosing ultra-sensitive PHI and obligations on persons or entities receiving ultra-sensitive PHI and discloses or withholds health information accordingly.

The SATVA method empowers relatively easy consented communication of ultra-sensitive health information between two or more providers that can communicate via the NwHIN Direct open specification or other appropriate, common transport protocol. SATVA’s Ultra-Sensitive Privacy Disclosure Implementation Guide (USPD IG) defines a small handful of disclosure purpose and recipient obligations added to Continuity of Care Documents (CCDs) or to the message envelope metadata. These coded obligations convey the intentions and expectations under which patients have signed locally maintained consent documents.

The SATVA method complies with all current U.S. standards for electronic HIE including the standards promulgated by HL7 and the S&I Framework. The SATVA method supports regulatory compliant USPD performed electronically between two electronic health records (EHRs) utilizing the SATVA USPDIG. However, the minimum requirement for receiving USPD under the SATVA method is a browser capable of displaying a CCD containing the USPDIG-described embedded legal notices, purpose of use restrictions and recipient handling obligations.

Overview

The SATVA DS4P Pilot Project for Ultra-Sensitive Privacy Disclosure (USPD) will develop, test, pilot and place into production standards-based interoperability for data in transit. SATVA methods will function for both HIE and NwHIN Direct interoperability. The SATVA implementation will demonstrate compliance with all 42 CFR Part 2 requirements as an example of a specific but extensible class approach to management of all ultra-sensitive disclosures. Electronic data exchange will support C32/CCDA records as well as non-structured payloads such as PDF. Testing will demonstrate interoperability between “foreign” (e.g., different software vendors) EHRs via NHIN Direct.

First production goals for the SATVA USPD IG include three basic disclosure scenarios:

  1. Push a 42 CFR Part 2 compliant CCD from one provider to another (e.g., when transitioning care inpatient to outpatient).
  2. Push a 42 CFR Part 2 compliant CCD that is a disclosure request to a provider that is asking that provider to respond with the requested disclosure. The provider responds by pushing a disclosure CCD back to the requesting provider.
  3. Push a non-42 CFR Part 2 compliant CCD that is a disclosure request to a provider that requires 42 CFR Part 2 compliance that is asking that Part 2 provider to respond with the requested disclosure. The Part 2 compliant provider responds with the "can neither confirm nor deny" message as required in such circumstances by 42 CFR Part 2.

For practical “treatment purposes” interoperating requires these three disclosure scenarios.

Secondary production goals include methods to “break the glass” and obtain records without patient consent but still in full compliance with 42 CFR Part 2 under the medical emergency exception.

Completing these production goals will build a platform extensible to other privacy regulations and other disclosure purposes.


Objectives

[Update in progress.]

Points of Contact

Software and Technology Vendors Association (SATVA)
John Leipold DBA, MBA
Executive Vice President / COO / Valley Hope Association
Chief Executive Officer / Valley Hope Technology
PO Box 510Norton, KS 67654 785.877.5111

[Other contacts in progress.]

Participant/Stakeholder Roles and Responsibilities

  • SATVA - Participant
    Project coordination, Sponsor
  • Valley Hope Association - Participant
    EHR, Push/Pull sender, ACS, sandbox test, production
  • Cerner Behavioral Health - Participant
    EHR, Push/Pull sender, ACS, sandbox test, production

Demonstrated Standards

  • Payload
    CCDA, C32, EDI, CCR, DICOM, PDF
  • Transport
    DIRECT, NwHIN Exchange
  • Privacy and Access Consent
    42 CFR Part 2
  • Security
    PKI, SSL, HTTPS
  • Standards
    HL7, C32/CCDA XDS.b, XDR, XDM, PKI, SSL, HTTPS

Ecosystem Diagram

[Update in progress.]


Pilot Project Timeline

[Update in progress.]


Anticipated Resources

  • SATVA
  • Interoperability Work Group / Project Coordinator
  • Valley Hope Association
  • Cerner Behavioral Health

  • Infrastructure
  • Cerner Behavioral Health, HISP
  • Cerner Behavioral Health, EHR
  • Valley Hope Association, EHR
  • S&I Framework assistance/support
    Facilitate collaboration with other DS4P pilots and with other participating DS4P experts

Success Metrics

[Update in progress.]

Reference Documents

[Update in progress.]

National Conference on Addiction Disorders, September 30, 2012, Orlando, FL

Document
Description

SATVA Presentation at National Conference on Addiction Disorders
SATVA NCAD Conference Pilot Preview Recording
Video recording of SATVA Pilot Presentation Preview at DS4P RI/Pilots Meeting 09/24/2012