FHIR Data Segmentation for Privacy (DS4P) Implementation Guide
1b. Project ID
1c. Is Your Project an Investigative Project (aka PSS-Lite)?
1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?
1e. Today's Date
May 21, 2019
2a. Primary/Sponsor WG
2b. Co-Sponsor WG
Clinical Quality Information
2c. Co-Sponsor Level of Involvement
Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
2c. Co-Sponsor Update Periods
2d. Project Facilitator
Mike Davis, Chris Shawn, Johnathan Coleman
2e. Other Interested Parties (and roles)
Current and Prospective Implementers, and possible Connectathon DS4P participants:
*Perspecta: Dr. McNamee CMIO, Bo Dagnall, Joyce Dunlop
*Debi Willis, PatientLink; President and Founder
*VA Mike Davis, VHA Security Architect, Chris Shawn, Security Cochair/VA, Mohammad Jafari & Kathleen Connor BZ/VA
Craig Newman and Matt Lord for Cross-Paradigm Security Label mapping
3a. Project Scope
Provide FHIR guidance for applying security labels with coded tags for use in access control systems governing the collection, access, use, and disclosure of the target FHIR Resource(s) as required by applicable organizational, jurisdictional, or personal "sharing with protection" policies.
The IG will include guidance on:
*Marking healthcare and personal information disseminated by US Federal agencies per Executive Order 13556 Controlled Unclassified Information (CUI), and US Code of Federal Regulations32 C.F.R. § 2002 in the Federal Register and the General Services Administration (GSA) policy and framework for Controlled Unclassified Information (CUI), 2103.1 CIO Controlled Unclassified Information (CUI) Policy.
*How to select a security label based on the HL7 Privacy and Security Healthcare Classification System (HCS) label adjudication algorithms, the value in establishing consensus on a default security label for representing policies or consent directives within an exchange ecosystem, and the value of establishing default security labels for information exchanged within the Trust Framework of a policy domain.
*How an Access Control System, such as an OAuth Authorization Server can use the security labels to filter responses to person/population based queries and pushed disclosures that meets:
- Authorization Requirements specifying control over whether or not a client’s request for import or export of person/population Resources will be permitted
- Filtering Requirements specifying, at a more fine-grained level, what resources will appear in the results of a person/population export or accepted in an import operation
- Transformation Requirements specifying the requirements for applying functions on imported or exported person/population Resources, which modify and transform the content of any Resource per applicable privacy/security policies and/or data subject's(s') consent directive
- Provenance Requirements specifying the recording and consumption of provenance information in a person/population Resource(s) export or import operation.
*Further development of HL7 security labeling vocabulary to enhance provenance and trust labeling to meet HL7 Provenance efforts including the PSAF Provenance DAM, Basic Provenance project, and updates to the CDA DPROV IG.
Addition of security label vocabulary to meet international affiliate needs, including GDPR security labeling vocabulary requirements determined by the Security WG GDPR WG.
Address the need to restructure FHIR Security label structure to enable demarcation of multiple applicable security labels into privacy tag sets representing each policy.
Develop a profile on Narrative to enable specification of the manner in which security label "privacy marks" are rendered, e.g., per CUI requirements.
3b. Project Need
To replicate and enhance the implementation guidance provided by the CDA Data Segmentation for Privacy IG and HL7 V2.9 security labeling segments in response to growing need in the US and internationally to share healthcare information with protections.
3c. Security Risk
3d. External Drivers
General Data Protection Regulation (GDPR), Trusted Exchange Framework for Common Agreement (TEFCA), CMS Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally Facilitated Exchanges and Health Care Providers CMS-9115-P, and ONC 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification
3e. Objectives/Deliverables and Target Dates
*Initiate project calls and modeling during January 2020 WGM to determine resource appropriate project milestones with focus on "low hanging fruit" approach to incrementally developing & balloting the IG.
*Continue IG development and guidance during the interim on FHIR Security calls
*Ballot as FHIR IG May 2020
*Connectathon test project artefacts being balloted in May
*Reconcile and revise IG @ May WGM and during interim May-August 2020.
*Ballot as FHIR IG September 2020
*Connectathon test project artefacts being balloted in September 2020
*Reconcile and revise IG @ September WGM and during interim September - December 2020
*Ballot as FHIR IG January 2021.
*Connectathon test project artefacts being balloted January 2021
*Reconcile and revise IG @ January 2021 WGM and during interim January - May 2021
*Rinse and Repeat IG Balloting, Testing, Reconcilation and Revsions as needed until approved standard.
3f. Common Names / Keywords / Aliases:
FHIR DS4P IG
CDA DS4P IG, HL7 V2.9 security labeling segments
3h. Project Dependencies
Approval/implementation of HL7 security labeling vocabulary within scope.
Approval of changes to FHIR Security Labeling structures and Narrative profile that supports rules for rendering privacy marks.
Input from a normative PSAF Provenance DAM, Basic Provenance project, and updates to the CDA DPROV IG.
4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?
R4 and v-next if established within IG development period.
4c. FHIR Profiles Version
R4 and v-next if established within IG development period.
5a. Project Intent
Create new standard
5b. Project Ballot Type
STU to Normative
5c. Additional Ballot Info
Plan to ballot FHIR DS4P IG components incrementally, e.g., starting with "low hanging fruit" change requests for a FHIR "security labeling lite" subset of the entire HCS security labeling vocabulary. We plan to develop a detailed project plan during the January 2020 WGM to align with funding/volunteer resources known @ that time, and to update as this alignment changes.
Regulatory Agency, Standards Development Organizations (SDOs), Payors, Other
6f. Other Stakeholders
HIT Vendors, Providers, Healthcare Consumers, HIEs
EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab, HIS
Clinical and Public Health Laboratories, Emergency Services, Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health), Other
6h. Other Providers
Community based and long term services and support providers