Vendors to self-declare PCEHR-compliant software

The National E-Health Transition Authority (NEHTA) has introduced new guidelines for medical software vendors looking to integrate their products with the PCEHR, which NEHTA says will make conformance with the national system faster and cheaper.

Software vendors have in the past undergone a conformance, compliance and accreditation (CCA) process that involved NEHTA observing vendors' software performing functions to show it conformed with requirements.

Vendors will now undergo a conformance, compliance and declaration (CCD) process to 'self-declare' conformance directly to the Department of Health (DoH), which is the PCEHR system operator.

A NEHTA spokesperson said this would make the process faster and cheaper for vendors, as removing the remote observation step would fit better with their product development cycles.

“Operationally, [NEHTA observation] didn’t sit well with a vendor’s software development process because it occurred at the very end of that process,” the spokesperson said.

“If errors were found, a vendor would need to go back through its internal development and test cycles before booking another ‘observed self-assessment’ with NEHTA.

“When NEHTA asked vendors how we could improve this, they advised they would prefer NEHTA to assist them earlier in the development of their software, and allow a vendor to ‘declare’ conformance once they had passed all the tests in their own integrated testing process.”

The spokesperson said vendors had also advised that doing conformance testing within their quality assurance process will also save them a significant amount of time.

“[It] will move conformance testing earlier in the development, rather than occurring at the end when it is more costly to fix errors,” the spokesperson said.

“This new scheme allows a vendor to further integrate conformance tests into their existing test plan throughout development, rather than as a ‘bolt-on’ after development is complete.”

NEHTA said the change had been welcomed by vendors and vendor associations, including the Australian Information Industry Association (AIIA), the Medical Software Industry Association (MSIA) and the Aged Care Industry Vendors Association (ACIVA).

While software conformance with the PCEHR is expected to be cheaper, the connection requirements for conformance and compliance with the Healthcare Identifiers (HI) Service and notice of connection (NOC) requirements for the PCEHR will remain unchanged. These are handled by the Department of Human Services.

Smaller vendors in particular have long complained about the cost of having to go through independent testing by accredited labs such as IV&V Australia or KJ Ross.

NEHTA is also releasing a new 'Clinical Package Validator' product to replace its CDA Validator that allows a vendor to feed in a clinical document and obtain a report of errors in the document. The spokesperson said the new product incorporates new functionality such as test reports and more configurable functions.

It has also set up a new PCEHR Developer site to help vendors through the specifications their software must comply with, the registration steps and the quality processes required.

“This has been road tested by new and veteran eHealth vendors who have unanimously said this tool will make eHealth software development much easier,” the spokesperson said.

Posted in Australian eHealth

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