Biomedical Research and Regulation

Mission

Updated May 18, 2017

The BR&R workgroup areas of interest encompass clinical and translational research, both regulated and non-regulated, and the subsequent regulatory submissions and information exchanges to bring new products to market and to ensure safe use throughout the product lifecycle. BR&R creates and promotes standards to facilitate biomedical research and any subsequent regulatory evaluation of the safety, efficacy and quality of medical products that may arise from research.

 

Charter

Work Products and Contributions to HL7 Processes

The BR&R performs the bulk of its work through projects with a clear line of sight to its scope. Examples include BRIDG (domain analysis model supporting research) and RPS (exchange message supporting medical product application submissions to regulators). 

This Work Group will facilitate the development of common standards and the maintenance and enhancement of the research-focused domain analysis model for clinical research information management across a variety of organizations, including national and international government agencies and regulatory bodies, private researchers and research organizations, sponsored research, CROs and other interested entities. A shared semantic view is essential if the clinical research community, both for itself and as part of the larger Healthcare and life sciences communities, is to achieve computable semantic interoperability. 

 

The BR&R will seek to assure that related or supportive standards produced by other HL7 groups are robust enough to accommodate their use in regulated clinical research through participation as appropriate, including ballots. The group will also monitor information interchange standards developed outside of HL7, and attempt harmonization of information content and representation of such standards with the HL7 content and representation.

 

The BR&R’s charge includes the maintenance of BR&R-produced standards until their useful life has been exceeded, either through discontinuance of use or through supersession by later versions of the standard. The portfolio of standards will be reviewed annually for active use, obsolescence, and potential need for change. When a standard is identified for withdrawal, the BR&R will make efforts to communicate to users or potential users of that standard well in advance of any withdrawal action. 

 

The BR&R will develop specifications using the principles and language of the Services Aware Interoperability Framework (SAIF) Canonical Definition (CD) and the restrictions and specializations of the HL7 SAIF Implementation Guide (IG) to ensure traceability from conceptual to logical to implementable specifications.

 

The term “regulated” or “regulation” refers to human and animal medical products and foods regulation.

 

Formal Relationships With Other HL7 Groups

• Clinical Genomics
• Clinical Interoperability Council
• Clinical Quality Information
• Electronic Health Record
• Emergency Care
• FHIR
• Health Care Devices
• Orders and Observations
• Patient Care
• Patient Safety
• Pharmacy
• Public Health and Emergency Response
• Structured Documents

Formal Relationship With Groups Outside of HL7

 

The BR&R maintains liaison relationships with appropriate national and international standard bodies subject to the approval of the HL7 Board, including at minimum CDISC and ISO TC 215 (and by reference, CEN TC 251).

Working Practices

Active Projects:

• Vetting project proposals (PSS)
  • Confirm that the project aligns with the BR&R mission & scope
  • Identify any standards existing or underway that should be leveraged (i.e., avoid duplication)
  • Determine who stakeholder groups are, identify whether the stakeholder groups are willing to commit to active engagement
• Composition of project teams
  • Teams will include stakeholders willing to commit to active engagement, subject matter experts, those required to manage a project (from PSS)
  • Each project must have a designated lead/spokesperson
    • The Lead/spokesperson can make decisions to keep projects working forward, but actions must be brought back to the Work Group for information/questions/concerns and may be subject to re-consideration
    • The Lead/spokesperson will be designated by consensus vote of the Work Group
    • Anything being taken to ballot must come to the full Work Group for review
• Assuring WG awareness of project progress and health
  • The Lead/spokesperson is charged with providing updates at regularly scheduled bi-weekly tcons and a more complete presentation at F2F meetings

Workgroup member obligations:

• Each workgroup member is responsible to bring to the Work Group’s attention any information that is relevant and could have impact on a standard or project

Annual and 3-year review:

• Standards are annually reviewed for active use, obsolescence, and potential need for change.
  • Active use includes available input on uptake of the standard or plans to implement
• The full portfolio and planned activities are reviewed every 3 years for health and relevance

Balloting:

• Ballots will include an introductory statement describing the impact of this new standard to any previous versions of the standard, for instance, whether or not the new revision is backwards compatible with previous versions and how far back.

Date of Last Revision

January 18, 2017