FHIR Catalog Support

Drivers ISO IDMP openMedicine (EU Project) (Orderable Lab Tests)

Goal To have one consistent approach to transfer “catalog” information List of prescribable medications List of orderable devices List of orderable services Including metadata / properties / expected behavior about orderable items

Use Cases: Hospital queries and retrieves list of authorized medications / devices from national authority Hospital publishes list of authorized medications /devices by departments Hospital systems (OR, EHR, Dispensing) consult list of medications All medications/devices Only updated since Aug-13 Physician queries the full properties for a device before implant Physician wants to order lab studies / other...

Catalog of Items - Approach Provide “catalog entries” to ensure each “items” has necessary definitional data Medication compatible with regulators (can contain all information defined and needed by the FDA / EMA) compatible with clinical use cases (can contain the common subset to be used in prescriptions, dispenses) Devices Compatible with Regulators Compatible with clinical uses, including UDI (implant, etc). Tests Compatible with furnishing labs, etc. http://ig.fhir.me/Healthedata1/fhirlabtestcatalog/ Create a resource for Catalog Bundling, Transmission handshake Date last submitted, Catalog entry valid until (not the same as physical device expiry),...

Catalog of Items – Scope exclusions Clinical Current clinical use cases (prescription, dispense, etc.) do not need to be changed. They need to be supported by the existence of a catalog Inventory management Quantities at hand, location, or whether items are physically in warehouse – not needed. Only need is “Items in catalog” Supply Deliveries, orders, etc. are already handled by Supply resources which already follow the approach: Generic “supply” resources which can use the “items” resources.

3 Projects Medication PSS – enable Medication Resources to be catalog-compatible Others: devices, etc. Would work the same. Medication is interesting for openMedicine and regulators. Lab Test PSS – “eDOS on FHIR” Cataloging mechanism PSS – provide the exchange mechanisms. Catalog Entry - Data Element? Activity Definition? XYZ Definition? Catalog

Stakeholders: OO RCRIM Pharmacy Terminologies FMG Medication (PSS 1) Devices Lab tests (PSS 3) ... CATALOG (PSS 2)

PSS 1: Medication formulary Defining a resource (or adjust the existing resource) to enable the exchange of product descriptions – not just to be able to specify the product from a formulary, but to actually fill in that formulary, echanging characteristics of a medication. ISO IDMP-ready resource Able to convey the product information generated at regulators, and enriched throughout the chain until reaching the clinical systems.

PSS 2: “Catalog” exchange Before a “medication” definition resource can be populated, there are several questions around the exchange of product information: Bulk download of product data? Or query mechanism to download as needed? How to handle differential updates? When updating one product (e.g. a Pharmaceutical Product), what to do with ancestors or descendants? Are they also updated? ...

PSS 3: eDOS on FHIR For a catalog consumer (order placer) to know which lab services are orderable, and all the characteristics – from pricing info to availability per provider. – Exchange characteristics of lab services. From lab providers to lab catalog broker, and from catalog broker to individual consumers

Open Questions Is FDA GUDID a type of Catalog with each Device being a Catalog Entry?  Yes Do we always need to exchange / provide access to a full Catalog? Individual Catalog Entries? A set of Catalog Entries?  Yes. And even a set of characteristics, or filter based on a set of characteristics. This is allowed by the handshake part + filtering Some cases: Get full catalog Get full catalog for “new “ items (changed after ddmmyyyy) Get updates for medications containing paracetamol Get the devices that do not have latex Get the lab services and locally defined prices… How does this relate to Ordering Service efforts? Needs to be harmonized.