Difference between revisions of "RegulatedAuthorization FHIR Resource Proposal"
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<!-- Additional work groups that may have an interest in contributing to, or reviewing the content of the resource (optional) --> | <!-- Additional work groups that may have an interest in contributing to, or reviewing the content of the resource (optional) --> | ||
| − | * Pharmacy | + | *Pharmacy |
==FHIR Resource Development Project Insight ID== | ==FHIR Resource Development Project Insight ID== | ||
| Line 50: | Line 50: | ||
==Scope of coverage== | ==Scope of coverage== | ||
| − | + | Regulated items - those subject to local, regional or international legislation for their use - are subject to authorization procedures and outcomes. | |
| + | |||
| + | These authorizations, and the items they relate to, need to be tracked and made available. | ||
| + | |||
| + | Regulatory systems keep full details of authorizations, and these may be referenced by other users to check the legal and usage parameters of a medicinal product, or a device. | ||
| + | |||
| + | In scope: | ||
| + | |||
| + | The item that is being authorized (e.g. reference to a product or device) | ||
| + | |||
| + | The holder (receiver) and the regulator (creator) of the authorization. | ||
| + | |||
| + | Type of authorisation - Marketing approval (or suspension), orphan drug approval, special uses for veterinary medication etc. | ||
| + | |||
| + | Status, e.g. pending, approved, withdrawn. | ||
| + | |||
| + | Location of applicability, local, regional, national etc. | ||
| + | |||
| + | Dates of application, granting, and associated dates such as special case initial periods, end dates, renewal dates etc. | ||
| + | |||
| + | The legal framework under which the authorisation was granted (e.g. EU CAP Centrally Authorised Product). | ||
| + | |||
<!--==RIM scope== | <!--==RIM scope== | ||
Similar in scope to the product parts of CPM. Entity: Material (EntityClass="MAT")--> | Similar in scope to the product parts of CPM. Entity: Material (EntityClass="MAT")--> | ||
| − | |||
==Resource appropriateness== | ==Resource appropriateness== | ||
| Line 61: | Line 81: | ||
Regulators (EMA, FDA, and national "Competent Authorities"), as well as more local organisations, hospital and payer networks etc, need to record the legal authorizations that apply to medicinal products. | Regulators (EMA, FDA, and national "Competent Authorities"), as well as more local organisations, hospital and payer networks etc, need to record the legal authorizations that apply to medicinal products. | ||
| − | This is a key focus of what organizations such as FDA and EMA do - they regulate and authorize the | + | This is a key focus of what organizations such as FDA and EMA do - they regulate and authorize the ability to make drugs available. |
==Expected implementations== | ==Expected implementations== | ||
| − | EMA and European drug manufacturers, who have a requirement to submit to EMA (and already do so in a proprietary format). | + | EMA and European drug manufacturers, who have a requirement to submit to EMA (and already do so in a proprietary format). The EU wide system is currently being redeveloped to use FHIR, and this data is directly in scope. |
| − | FDA for | + | FDA for Drug Submission (currently using SPL, which is not likely to change in the near term, but have expressed an interest in FHIR). |
FDA for Pharmaceutical Quality (HL7 PSS approved, based on this resource, June 2019), | FDA for Pharmaceutical Quality (HL7 PSS approved, based on this resource, June 2019), | ||
| Line 73: | Line 93: | ||
==Content sources== | ==Content sources== | ||
| − | The core basis for the resource is | + | The core basis for the resource is information currently used by FDA (as SPL) and the EMA EU XEVMPD data base (and XEVPRM XML messages). |
| − | |||
| − | |||
| − | Also from | + | Also, information gained from early stage implementation of this resources at EMA (2018, 2019), and from many many received to EMA about the draft API specification from the European medicines regulatory network (https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network). |
==Example Scenarios== | ==Example Scenarios== | ||
| Line 83: | Line 101: | ||
Pharma companies submit details of new products to regulators, and include authorization details, which in turn may be updated by the regulators. | Pharma companies submit details of new products to regulators, and include authorization details, which in turn may be updated by the regulators. | ||
| − | Pharmacies and prescribers can view and download this information for reference and integration with their systems. | + | Pharmacies and prescribers can view and download this information for reference and integration with their systems. They may be able to see why a product was withdrawn for instance. |
Specific use cases include: | Specific use cases include: | ||
| Line 96: | Line 114: | ||
Some notable resource references: | Some notable resource references: | ||
| − | + | ||
| − | + | To Organization, for the licence holder and the regulator that established the authorization/licence. | |
| + | |||
| + | To a MedicinalProductDefinition or PackagedProductDefinition (authorization can happen at different levels, per specific pack, or product wide), or a DeviceDefinition, as the subject, that is authorized. | ||
| + | |||
Also refer to the logical model which was used to clarify the resource relationships, at the request of FMG, in the preparation of this proposal (linked to the approved MedicationKnowledge proposal page): [[MedicationKnowledge_FHIR_Resource_Proposal]] | Also refer to the logical model which was used to clarify the resource relationships, at the request of FMG, in the preparation of this proposal (linked to the approved MedicationKnowledge proposal page): [[MedicationKnowledge_FHIR_Resource_Proposal]] | ||
| − | |||
High level relationships of the main prescribing resources and the regulatory strata below: | High level relationships of the main prescribing resources and the regulatory strata below: | ||
Revision as of 16:41, 28 August 2019
This page documents a Pending FHIR Resource Proposal
Contents
- 1 RegulatedAuthorization
- 1.1 Owning work group name
- 1.2 Committee Approval Date:
- 1.3 Contributing or Reviewing Work Groups
- 1.4 FHIR Resource Development Project Insight ID
- 1.5 Scope of coverage
- 1.6 Resource appropriateness
- 1.7 Expected implementations
- 1.8 Content sources
- 1.9 Example Scenarios
- 1.10 Resource Relationships
- 1.11 Timelines
- 1.12 gForge Users
- 1.13 When Resource Proposal Is Complete
- 1.14 FMG Notes
RegulatedAuthorization
Draft resource in build:
Owning work group name
Committee Approval Date:
6th May 2019 (earlier approval as "MedicinalProductAuthorization" 13th September 2017)
Contributing or Reviewing Work Groups
- Pharmacy
FHIR Resource Development Project Insight ID
1367
Scope of coverage
Regulated items - those subject to local, regional or international legislation for their use - are subject to authorization procedures and outcomes.
These authorizations, and the items they relate to, need to be tracked and made available.
Regulatory systems keep full details of authorizations, and these may be referenced by other users to check the legal and usage parameters of a medicinal product, or a device.
In scope:
The item that is being authorized (e.g. reference to a product or device)
The holder (receiver) and the regulator (creator) of the authorization.
Type of authorisation - Marketing approval (or suspension), orphan drug approval, special uses for veterinary medication etc.
Status, e.g. pending, approved, withdrawn.
Location of applicability, local, regional, national etc.
Dates of application, granting, and associated dates such as special case initial periods, end dates, renewal dates etc.
The legal framework under which the authorisation was granted (e.g. EU CAP Centrally Authorised Product).
Resource appropriateness
There is an outstanding requirement to support the standardised exchange of detailed "Product" data, for regulatory and other use cases.
Regulators (EMA, FDA, and national "Competent Authorities"), as well as more local organisations, hospital and payer networks etc, need to record the legal authorizations that apply to medicinal products. This is a key focus of what organizations such as FDA and EMA do - they regulate and authorize the ability to make drugs available.
Expected implementations
EMA and European drug manufacturers, who have a requirement to submit to EMA (and already do so in a proprietary format). The EU wide system is currently being redeveloped to use FHIR, and this data is directly in scope.
FDA for Drug Submission (currently using SPL, which is not likely to change in the near term, but have expressed an interest in FHIR).
FDA for Pharmaceutical Quality (HL7 PSS approved, based on this resource, June 2019),
Content sources
The core basis for the resource is information currently used by FDA (as SPL) and the EMA EU XEVMPD data base (and XEVPRM XML messages).
Also, information gained from early stage implementation of this resources at EMA (2018, 2019), and from many many received to EMA about the draft API specification from the European medicines regulatory network (https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network).
Example Scenarios
Pharma companies submit details of new products to regulators, and include authorization details, which in turn may be updated by the regulators.
Pharmacies and prescribers can view and download this information for reference and integration with their systems. They may be able to see why a product was withdrawn for instance.
Specific use cases include:
Submission of products from drug companies and NCAs (National Competent Authorities - the national regulators) to regional regulators.
This is already implemented in Europe (by EMA and EU-wide stakeholders) with an earlier non-HL7 format (XEVPRM/XEVMPD). That scenario is currently being re-implemented, using this resource, as part of the EU wide SPOR project.
Resource Relationships
See diagram below.
Some notable resource references:
To Organization, for the licence holder and the regulator that established the authorization/licence.
To a MedicinalProductDefinition or PackagedProductDefinition (authorization can happen at different levels, per specific pack, or product wide), or a DeviceDefinition, as the subject, that is authorized.
Also refer to the logical model which was used to clarify the resource relationships, at the request of FMG, in the preparation of this proposal (linked to the approved MedicationKnowledge proposal page): MedicationKnowledge_FHIR_Resource_Proposal
High level relationships of the main prescribing resources and the regulatory strata below:
Timelines
Draft content is modelled in the FHIR build (http://build.fhir.org/regulatedauthorization.html), with outline supporting documentation. Completion planned Q4 2019.
gForge Users
riksmithies
When Resource Proposal Is Complete
When you have completed your proposal, please send an email to FMGcontact@HL7.org
