OnCo
ideasIdea

Certify every oncology software product for a standard bulk data export

Regulators would test and certify that every hospital cancer system can export its records in a standard format, the way electrical appliances are certified safe.

The US ONC certification programme already requires certified EHRs to support FHIR Bulk Data (Flat FHIR) export for the USCDI core data set, but oncology-specific systems (treatment planning, chemotherapy prescribing, molecular reporting, radiotherapy oncology information systems) are largely outside it. The proposal extends certification criteria to oncology systems with mCODE and DICOM-RT profiles, tested by a public conformance suite, so that a cancer centre can pull all of a patient's data through one standard interface.

Hypothesis
If oncology systems must pass a public conformance test to be sold to publicly funded providers, integration cost per cancer centre for research data extraction falls by more than half within five years and the number of centres contributing to national datasets doubles.
Rationale
Certification with public conformance testing created the FHIR API ecosystem in US general medicine within a decade; the same lever has not been applied to oncology-specific vendors, which is where the richest data sit.
What would test it
Publish an open conformance test suite for oncology bulk export (mCODE plus DICOM-RT) and run it against the ten largest oncology systems; publish results. If vendors fail and do not fix within a year, that is the case for making certification mandatory in procurement.
Maturity
speculative
Who has to act
regulator
Cost to try
Medium ($1M to $50M)
Years to first evidence
4
Bottlenecks it attacks
  • Data silos · Records, scans, genomes and outcomes sit in separate systems that cannot talk. Every patient's experience is lost to the next.

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AI & Computation

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ElektaVarian (Siemens Healthineers)

bottlenecks

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Data silos