NEHTA, Yet Again, Just Misses the Point With Approach for Conformance and Certification.

In the last few days we have had the following press release from NEHTA

Industry heavyweights unite on Australian e-health software standards

4 December 2009. Consensus reached on a new direction for product compliance and conformance assessment.

Four peak industry groups have joined with the National E-Health Transition Authority (NEHTA) to develop a standards assessment approach for medical software in Australia.

A joint statement released this week defines the principles on which compliance, conformance and certification of software products will be based and outlines a cost-effective pathway to standards development using existing industry mechanisms.

The consensus statement represents a landmark agreement between heavyweights in Australia’s medical software and standards compliance industry including the Medical Software Industry Association (MSIA), Australian Information Industry Association (AIIA), National Association of Testing Authorities (NATA) and Joint Accreditation System of Australia & New Zealand (JAS-ANZ).

It also addresses issues of concern for the commercial software industry, helping to clarify market confusion around roles and processes, and guiding NEHTA in the development of Australia’s premier e‑health conformity assessment scheme.

Conformity assessment will be based on existing national and international standards and will focus on the specific software functionality components that align with NEHTA requirements.

A tiered system, ranging from self-assessment through to accredited external assessment, will be introduced to minimise the time and cost of compliance in line with product risk.

Where appropriate, external third-party assessment will be undertaken by independent agencies accredited through internationally-recognised accreditation organisations, such as NATA and JAS-ANZ in Australia.

NEHTA Chief Executive Peter Fleming applauded the agreement as a milestone in private-public sector collaboration and a significant step in the development of a national e-health infrastructure for Australia.

“The development and adoption of national specifications, and a supporting standards framework, is critical for improving patient care and healthcare delivery for all Australians,” he said.

“When systems work better together, the efficiency and accuracy of transactions improve, which creates a positive flow-on effect for clinical safety and quality.”

Read the Consensus Statement here.

Release is here:

http://www.nehta.gov.au/media-centre/nehta-news/569-cca

And when you follow the link you arrive here:

http://www.nehta.gov.au/connecting-australia/cca

E-Health Compliance and Conformance

To achieve the promised benefits that e-health offers, it is important for healthcare providers and medical software vendors to comply with e-health specifications and standards.

Compliance with these standards has two requirements:

• conformance in the way medical software systems implement the relevant e-health specifications and standards
• compliance by organisations that operate an e-health system or supply an e-health service with the relevant laws, codes of conduct, industry standards and principles of good governance.

Conformance, which relates to how products and services implement e-health specifications, is generally conducted through self-assessment by the party implementing the software system or by an independent third party such as a test laboratory. Conformance may also be assessed by a second party, such as a healthcare provider that is evaluating a software system prior to purchase.

Compliance, which ensures consistency among e-health specifications, usually takes the form of self-assessment, but may also be performed by an independent inspection body.

Assessment scheme
NEHTA is creating an Assessment Scheme for each of its major e-health specifications. The documentation will describe the process for assessing compliance and conformance for NEHTA’s e-health specifications and the assistance that NEHTA provides to organisations performing the assessment.

The Assessment Scheme documentation will give the following information:

• who may perform assessment (e.g. the scope of self assessment and the role of independent test laboratories and inspection bodies)
• guidance concerning assessment methods, test specifications and test tools
• levels of conformance and the timeframes for achieving conformance
• guidance concerning conformance claims by implementers and the presentation of assessment results.

For most e-health specifications, NEHTA will also provide conformance test specifications and a comprehensive list of test cases to be used in conformance testing. NEHTA may also provide test software and assistance in understanding e-health specifications.

Assistance for procurers

NEHTA provides assistance to healthcare providers procuring an e-health system with regard to tender specifications and evaluation. In particular, NEHTA can help in correctly stating compliance and conformance requirements in tender specifications. NEHTA also makes available to procurers its conformance test specifications and test tools to assist in evaluating candidate e-health systems.

Contact

David Manfield, Manager: Compliance, Conformance and Accreditation –david.manfield@nehta.gov.au

A slightly different consensus statement – with signatures and all is found here:

http://www.nehta.gov.au/component/docman/doc_download/908-cca-consensus-statement

This reads:

Leaders in Medical Software and Compliance, Conformance and Accreditation working together for e-health

Leaders in the Australian health software industry and compliance, conformance and accreditation (CCA) community demonstrate their ongoing commitment to the development of e-health by a declaration of consensus to work towards compliant and conformant e-health systems in the industry.

This statement is a commitment to the collaborative development and adoption of national e-health standards and the supporting CCA framework to improve patient safety and the quality of healthcare delivery for all Australians.

The Medical Software Industry Association (MSIA), Australian Information Industry Association (AIIA), National Association of Testing Authorities (NATA), Joint Accreditation System of Australia & New Zealand (JAS-ANZ) and the National E-Health Transition Authority (NEHTA) have achieved consensus on the following:

1. The focus in e-health for Conformity Assessment will be on specific functional capabilities of software products.

2. International and Australian standards will be used as the basis for conformity assessment.

3. A tiered approach to conformity assessment will be undertaken when applying conformity assessment for quality, safety and risk-based measures.

- Contingent on the risk involved, conformity assessment may consist of options from self-assessment through to accredited external assessment.

- Conformity assessment will be commensurate with risk and geared to minimise resources and time.

4. Accredited conformity assessment bodies (CABs) will be responsible for accredited external testing and certification.

5. Accreditation of CABs will be carried out by internationally recognised accreditation organisations, such as NATA and JAS-ANZ.

6. It is not the intention of NEHTA to become or perform the function of a CAB.

7. Existing and future conformity assessment bodies, such as AHML, will be leveraged as the basis for e-health conformity assessment.

8. Successful completion of an appropriate CCA process will be publicly recognised.

9. Whilst the CCA Framework’s primary focus is safety and quality, it will guide and assist other processes such as procurement and healthcare practice improvement.

10. The CCA Framework will focus on the foundations for e-health underpinning innovative development.

Signatures

End document.

Presumably this is all done in response to this undertaking:

Month: July

Initiative

Conformance, compliance and accreditation

Explanation: (Ensuring that software complies with Australian Standards and NEHTA specifications)

Outcome

A document describing how a national certification authority for eHealth related software will function will be completed during July.

See here:

http://aushealthit.blogspot.com/2009/12/what-did-nehta-promise-senate-to.html

By way of contrast in the last few days we have also had the following from Canada

http://www.infoway-inforoute.ca/lang-en/about-infoway/news/news-releases/508-canada-health-infoway-expands-certification-services

Canada Health Infoway expands Certification Services

'Infoway Certified' mark shows products meet pan-Canadian standards

November 30, 2009 (Toronto, ON) – Canada Health Infoway (Infoway) has added four new offerings to its pre-implementation Certification Service. Health information technology vendors can now receive certification for consumer health applications, client registries, provider registries, and immunization registries.

Receiving the 'Infoway Certified' mark provides vendors of health information technology products a competitive advantage in the marketplace by signalling their commitment and leadership to pan-Canadian standards and best practices.

"The certification mark signals a level of quality to buyers," says Richard Alvarez, CEO of Canada Health Infoway. "It tells the buyer that a vendor’s solution meets pan-Canadian standards and will increase the recognition, acceptance and adoption of trusted, interoperable health information technology solutions in the Canadian marketplace."

Infoway is the only organization in Canada certifying health information technology systems against pan-Canadian electronic health record (EHR) standards. Having produced national interoperability standards and a technology framework for the sustainable development of an interoperable EHR system across Canada, Infoway is well positioned to ensure current and emerging products provide required privacy and security and can interoperate with the EHR systems being implemented across the country.

The four new offerings join the pre-implementation Certification Services for consumer health platforms, which was launched in February 2009.

Canada Health Infoway is an independent, not-for-profit organization funded by the federal government. Infoway jointly invests with every province and territory to accelerate the development and adoption of electronic health record projects in Canada. Fully respecting patient confidentiality, these secure systems will provide clinicians and patients with the information they need to better support safe care decisions and manage their own health. Accessing this vital information quickly will help foster a more modern and sustainable health care system for all Canadians.

Backgrounder

Go to the e-Health Certification Section

Release here:

http://www.infoway-inforoute.ca/lang-en/about-infoway/news/news-releases/508-canada-health-infoway-expands-certification-services

and this from the CCHIT is the USA

Three EHR systems pass stimulus certification

By Joseph Conn / HITS staff writer

Posted: December 1, 2009 - 11:00 am EDT

Three electronic health-record systems are the first to pass muster with the Certification Commission for Health Information Technology under its new preliminary testing program for compliance with the "meaningful-use" criteria under the American Recovery and Reinvestment Act of 2009, the Chicago-based not-for-profit organization has announced.

The three products are eHealth Made Easy, Version 3, by eHealth Made Easy, supporting two of 27 applicable meaningful-use objectives for eligible providers and two of 24 applicable objectives for hospitals; KIS Track, Version 5.1, by Kaulkin Information Systems, supporting two of 27 applicable objectives for eligible providers; and Medios, Version 4.5, by IOS Health Systems, supporting 27 of 27 applicable objectives for eligible providers, according to CCHIT.

The new testing regime differs from previous CCHIT certification programs in that it does not require that a vendor pass all test criteria. Checklists of those criteria passed for each product are listed on the CCHIT Web site.

More here:

http://www.modernhealthcare.com/article/20091201/REG/312019985

Similar news is provided here:

CCHIT Certifies First EHR Programs Under Federal Standards

John Commins, for HealthLeaders Media, December 1, 2009

The Certification Commission for Health Information Technology today announced the first group of four electronic health records programs certified under its two programs—CCHIT Certified 2011 Comprehensive and Preliminary ARRA 2011.

Both programs inspect EHR technology for the first time against proposed federal standards to support providers in qualifying for 2011-2012 incentives under the $787 billion American Recovery and Reinvestment Act.

"These first four health IT companies, demonstrating their compliance with the proposed federal standards, are now able to offer certified products to providers who wish to purchase and implement EHR technology and achieve meaningful use in time for the 2011-2012 incentives," said commission Executive Director Alisa Ray. "We've had about 25 applications in our 2011 programs and inspections are continuing. Look for additional announcements from these early applicants in the upcoming days and weeks."

More here:

http://www.healthleadersmedia.com/content/242778/topic/WS_HLM2_TEC/CCHIT-Certifies-First-EHR-Programs-Under-Federal-Standards.html

What to say?

First, we still – months late - do not really have an explanatory document worthy of the name.

Second we learn we are to be certifying for compliance with “relevant laws, codes of conduct, industry standards and principles of good governance.”, and second that we are looking for conformance with NEHTA Standards once the assessment mechanisms are worked out.

Vendors are hardly going to push into illegality and defiance of codes of conduct etc!

Third – to the amazement of all – where is Standards Australia and IT-14 in all this? As I read it they seem to not be involved, did not sign off, and one can only ask why as the legal Commonwealth Standards setting entity, from which NEHTA claims to be a Standards taker from seems to out in the cold?

Fourth MSIA is hardly an organisation which has supported interoperability and data portability to date (think GP practice systems) and the other organisations do not – as far as I know have any specific e-Health expertise as far as standards etc are concerned.

Fifth, why are not clinical useability, functionality, contribution to patient safety of software and system etc at the top of the agenda. The answer is that compared with the Canadians and Americans the NEHTA technocrats are in a totally different and clinically detached space.

Sixth, what is all this about self assessment? That is hardly a way to ensure things are done right. As President Regan said “Trust but verify!”

So what we have is a silly announcement from a group that excludes the key player and which does not address the real issues around clinical software and its optimal use!

And people wonder why sometimes I am just a little bit grumpy.

David.