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1a. Project Name

US Medications Implementation Guide Update

1b. Project ID

1393

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?

No

1e. Today's Date

1f. Name of standard being reaffirmed

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Pharmacy

2b. Co-Sponsor WG

Public Health

2d. Project Facilitator

Brett Marquard and Nagesh Bashyam

2e. Other Interested Parties (and roles)

Clinical Quality Improvement

2f. Modeling Facilitator

Brett Marquard

2g. Publishing Facilitator

Nagesh Bashyam

2h. Vocabulary Facilitator

2i. Domain Expert Representative

Melva Peters

2j. Business Requirements Analyst

Nagesh Bashyam

2k. Conformance Facilitator

2l. Other Facilitators

2m. Implementers

Outreach in progress

3a. Project Scope

Prescription Drug Monitoring Programs (PDMPs) are databases deployed in each US State to track controlled substance prescriptions in a state. PDMPs provide health authorities timely information about prescribing and patient behaviors.
Full Background on PDMPs is provided by CDC (https://www.cdc.gov/drugoverdose/pdmp/states.html).

PDMPs primarily exchange information with an EHR using a non-HL7 standard (NCPDP).

HL7 published the original version of the US Medications implementation guide based on FHIR R3 in 2017 to provide guidance for patient and provider access to patient medications. A future release improved the guidance, and added a section mapping FHIR to NCPDP and PMIX to support PDMP exchange. The PDMP FHIR mappings are FHIR 3 based, and based on prior industry standards.

Broad industry adoption of FHIR R3 in the US did not occur, and the latest US regulation requires certified HIT systems support FHIR R4, and US Core.

Fortunately, many of the lessons from the US Meds guide were included in the US Core upgrade to FHIR R4. For example, the following guidance is now included in US Core:
• Fetching All Medications, Active Medications, and All Medications for an Encounter
• Get All Medications
• Get All Active Medications
• Get All Medications for an Encounter

The MedicationDispense and MedicationAdministration profiles are not included in US Core due to minimal adoption.

This project will upgrade the PDMP mappings to FHIR R4, addAmerican Society for Automation in Pharmacy (ASAP) mappings, upgrade the MedicationDispense/MedicationAdministration profiles to FHIR R4, and remove any Medication List guidance from the guide, and any profiles, that are superseded by US Core.

This project will not enhance US Core profiles, nor provide additional guidance on profiles that belong in US Core. Any relevant lessons for US Core will be logged as trackers for a future US Core release.

Attachments

3b. Project Need

Prescription Drug Monitoring Programs are being deployed in every state in the US to address prescription drug misuse, abuse, and diversion. They provide critical health information to physicians and other health care providers about an individual’s history of controlled substance prescriptions.

The current connections from PDMPs primarily utilize non-HL7 standards. This project plans to give guidance on using FHIR for application developers to connect with and exchange information with PDMP systems.

3c. Security Risk

No

3d. External Drivers

None

3e. Objectives/Deliverables and Target Dates

Submit for STU Ballot August 2020
STU Reconciliation September - December 2020
Request STU Publication January 2021
Close project February 2021

3f. Common Names / Keywords / Aliases:

PDMP, ASAP

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/FHIR-ONC-Meds

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

3m. External Vocabularies

Unknown

3n. List of Vocabularies

3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Supplement to a current standard

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

5d. Joint Copyright

No

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

no

6a. External Project Collaboration

6b. Content Already Developed

6c. Content externally developed?

6d. List Developers of Externally Developed Content

6e. Is this a hosted (externally funded) project?

6f. Stakeholders

Other

6f. Other Stakeholders

Patients

6g. Vendors

EHR, PHR

6g. Other Vendors

6h. Providers

Local and State Departments of Health

6h. Other Providers

6i. Realm

U.S. Realm Specific

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

7b. Sponsoring WG Approval Date

Apr 20, 2020

7c. Co-Sponsor Approval Date

7c. Co-Sponsor 2 Approval Date

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date



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