×

To enhance security, Multi-Factor Authentication (MFA) is mandatory for all HL7 users. More information

 

Cross-Paradigm Sensitive Data and Sensitivity Flags Library and Guidance (Jira PSS-2570)

Basics

Cross-Paradigm Sensitive Data and Sensitivity Flags Library and Guidance (Jira PSS-2570)

1934
Ballot - STU


FHIR Implementation Guide

Create New Standard

Details

This project aims to develop, publish, and maintain:

an open library/inventory of sensitive data sets that are subject to jurisdictional privacy rules and associated sensitivity flags that represent presences of certain sensitive data in a message, document, data set, or context where such presences is relevant to communicate;

an open library of computable expressions, e.g., CQL using FHIR resource definitions, that represent the jurisdictional privacy rules using the sensitive data and sensitivity flag definitions;

an open library of common, computable patient consent rules and the data they apply to;

a process supporting definition, inclusion and publication of new and updated entries (sensitive data, sensitivity flags, privacy rules, common consent rules)

One of the goals is to enable detection of sensitive information in context and data set enabling appropriate filtering of data upon access, exchange, and use including LLM processing to identify presence of sensitive information in context, unstructured data, data sets, and/or documents. These will enable developers to detect presence of sensitive information (e.g., using LLM or other tools) in documents, free text, contextually, images, medical device associations, or data sets, and appropriately tag data, documents, messages, free text, and data sets accordingly. Guidance on how to utilize the entries in specific exchange standards are addressed in standard specific guidance, specifically, HL7 DS4P for FHIR or CDA. Where such guidance is not yet published, e.g., Hl7 v2, the project will work with the standards management team to have such guidance established published as well.

The approach is to initially focus on sensitive data in the US, initially focusing on the requirements for California and Maryland followed by other US jurisdictions as they emerge. As non-US jurisdictional examples emerge, we will consider adjusting the scope from US Realm to Universal upon determining that they can be managed the same. The approach must be able to support use of sensitive data in any context such as US 42 CFR Part 2 for Behavioral Health, demographic and social determinants of health data, HIV, etc.

The resulting documentation will be published by HL7 and is available to anybody for their use for free per regular HL7 practice where the users can freely use the content within the applicable law of their jurisdictions.


Increasingly, jurisdictions are establishing data sharing privacy rules that involve restrictions on sharing targeted sensitive data, e.g., US Federal level – HIPAA and 42 CFR Part II, State Level – California AB 352 and Maryland Senate Bill 541, [non-US examples within countries welcome!]. These rules are independent of the exchange formats and methods used, i.e., cross-paradigms, including non-HL7 standard and any proprietary formats and methods. At the same time the determination whether to share data is based on patient data sharing consent rules as well (as requested or approved by another party, or by the patient pro-actively on their intent of what they consider to be sensitive data that may or may not be covered by jurisdictional privacy rules).

Developers therefore have a need to clearly understand the sensitive data subject to the variety of privacy rules across jurisdictions nationally and internationally, the sensitivity flags used to indicate presence of such sensitive data as needed and agreed when communicating as part of free text, documents, data sets and when based on context. For example, medications that in and of themselves are not indicative of sensitive conditions, but in combination with other data would require context specific flagging. Health IT needs to be able to support users identifying what can be shared or not based on the privacy rules and patient data sharing consent rules, thus requiring agreed to computable rules reflecting the jurisdictional privacy rules, thus reducing under-sharing or over-sharing. Additionally, having a set of commonly used, computable patient data sharing consent rules would enable consistent documentation and recognition of data subject to a patient’s consent rules.

Having a common library or set of libraries that reflect these data, flags, and rules, enables standards developers and implementers to consistently use, thus consistently scale, applying these rules and data to their solutions. Within HL7 that specifically means that the guidance on how to include and convey this information within the v2, CDA, and FHIR standards and their implementation guides, through various DS4P guides, can be fully harmonized and aligned, so the same data shared through different means can be managed the exact same.



Cross Paradigm IG - R1, STU Ballot - Target: 2025 Sep Ballot cycle


https://jira.hl7.org/browse/PSS-2570

SHIFT, Sequoia Project, Stewards of Change Institute, Civitas, ASU SHARES (Substance use HeAlth REcord Sharing), Connected for Better Health

Jurisdictional engagement to define and endorse privacy rules and sensitive data definitions. Security and CBCP workgroups for alignment with DS4P guidance; V2 Mgmt for alignment/creation of v2 guidance; FAST and clinical community (internal/external to HL7, e.g., external SHIFT, Stewards of Change, Sequoia Project, and internal Pt Care, CBCP, other) for alignment on patient data sharing consent rules.

Other (specify in Misc. Notes below)

Oracle Health, Meditech

Jurisdictional privacy legislation and regulations, automated data sharing at scale

Name/Alias: Data Sharing Rules and Guidance, Patient Requested Restrictions, Granular Data Segmentation, Granular Consent Management


Yes

N/A

No

2025 June: TSC approved project Stakeholders: Academic/Research, Association/Goverment Agency, Consultant, Healthcare IT Vendors, Healthcare Provider/user, Patients, Payer/Third Party Administrator, Providers, Regulatory Agency, Standards Development Organizations (SDOs), Vendor/Manufacturer
Organization & Realm

Realm Specific - Enter "U.S." or name of HL7 Affiliate below

US
People

Hans Buitendijk



Cross-Group Projects Work Group

Community-Based Care and Privacy (CBCP) Work Group; Implementable Technology Specifications Work Group; Security Work Group

Status & Dates

Active

Active Project (Resources assigned to pjt)

04/24/2025

05/01/2030

2030 May WGM/Ballot

09/15/2027

2027 Sept WGM/Ballot

Leave blank until NIB is submitted
Approvals

06/30/2025








US Realm -- Agreed -- (PSS-2626)
System Info

253301

PSS-2570



04/21/2026

Anne Wizauer