Tuesday, March 20, 2012

The Senate Community PCEHR Inquiry - Some Reflections and Comments. We Live In Interesting Times!

Well we had the inquiry report released yesterday and by now some of the press have started to provide some commentary.
We have this for example.

Concerns raised over e-health plan

  • by: Karen Dearne
  • From: Australian IT
  • March 20, 2012 10:28AM
THE results of a Senate inquiry into the Gillard government's Personally Controlled E-Health Record Bills have split along party lines, with the Labor majority recommending the bills be passed and Coalition senators calling for a delay until July 1 next year so that unresolved issues can be addressed.
In "additional comments" on the main report, the Greens have recommended five amendments to enhance the legislation, including greater privacy protections.
The PCEHR Bills will now be debated in the senate, following their passage in the lower house last month.
However coalition MPs raised a number of concerns over the PCEHR system and implementation arrangements; they flagged their intention to move amendments to the legislation pending the inquiry outcome.
Both sides report concerns with the performance of the National E-Health Transition Authority, tasked with delivering the system.
While submissions to the inquiry voiced support for a national e-health record system, "submitters identified particular aspects of the proposed system that they suggest require further amendment" before implementation.
"Principal among the issues raised were concerns that the proposed governance structures will not provide adequate transparency and accountability; and a concern that as the level of functionality of the system on implementation cannot be guaranteed, the PCEHR rollout may not be as successful as intended."
The report recommends a review of the operation of the Act in two years' time to "specifically consider the appropriateness of the vesting of the System Operator responsibility in the (Health department) secretary as well as possible alternative governance" structures.
"We are supportive of the aims of an e-health system and recognise that effective implementation will improve patient outcomes, particularly for consumers in rural and remote parts of Australia," it said.
"The committee acknowledges the magnitude of implementing the PCEHR system.
Lots more here:
There is also a report on the Report found here:

Senate Committee gives PCEHR tick of approval

The PCEHR is set to go ahead following the release of a Senate Committee report giving the controversial electronic record the legislative thumbs up.
Although the Senate hearings, which took place in February, were characterised by criticism of the healthcare record and of NEHTA, the Senate Community Affairs Committee also found there was widespread community and institutional support for the ehealth transformation of Australia’s healthcare system. Despite the Committee’s support, however, its report also noted concerns about governance, transparency and privacy. 
Lots more here, with a discussion of Opposition concerns at the end of the article.
We also have this:

Delay launch of PCEHR for a year - Senators

With only three months to go before the launch of the PCEHR, opposition Senators say the rushed program faces too many problems and unanswered questions and should be delayed for a year.
A Senate inquiry into the PCEHR program has divided along party lines, with the Opposition saying the short timeframe for implementation is unrealistic and that there are still unresolved issues around patients being unable to control who has access to their records,  governance and the complex infrastructure of the system.
Even government Senators acknowledged there were major concerns over implementation of the PCEHR system, and noted that most stakeholders preferred an opt-out system rather than the current opt-in model.
.....
They suggest that the PCEHR legislation be deferred until July 2013.
In a 6minutes website poll 84% of the 166 respondents have said they are not prepared to offer the PCEHR on its launch date of July 1.
Full article here:
The poll result is very interesting indeed.
As far a general comments are concerned here are mine.
First it is clear that NEHTA has not gained the trust of either the Government or Opposition as far as the PCEHR is concerned and that the Senior Executive of NEHTA should consider their position(s). The parliament represents the people and this lot have simply failed. This view is reflected in many parts of the report. I have pulled them out here:
Second I believe that no one has asked and certainly no-one has answered the six questions I raised regarding the PCEHR in my Submission. Unless we know the why the PCEHR, is there real evidence to support doing it, is it really safe, can security and privacy really be protected etc. (see AusCERT material from the last few days) ferreting around in the minutiae of NEHTA vs MSIA will have us all loose.
Each of these questions needs proper detailed and convincing responses. Lack of response to these issues really makes the report, in some ways, a bit of a sideshow - rather than the main game. We should be asking is the PCEHR justified, will it really work and make a difference and how can we know without a detailed review that has never been done?
Third it is a bit sad the Committee did not engage some experts to sort fact from fiction in all the to and fro of the debate.
Fourth it is hard to reconcile what the Committee was told with the recommendation from the Committee Majority to just ‘pass the bills’ - on a wing and a prayer that all will be great in the end!
Major issues discussed in the majority report were Governance, The Independent Advisory Council, PCEHR Functionality, Opt In vs. Opt Out, Patient Safety, Definitions, Nominated Providers, Privacy and Access
There were 3 recommendations from the Majority members of the committee.
Recommendation 1
2.24 The committee recommends that the review of the operation of the Act that will occur after two years pursuant to Clause 108 specifically consider the issue of the appropriateness of the vesting of the System Operator responsibility in the Secretary of the Department of Health and Ageing as well as possible alternative governance structures.
Recommendation 2
2.46 The committee recommends that the review of the operation of the Act that will occur after two years pursuant to Clause 108 consider the opt-in design of the system including consideration of the feasibility and appropriateness of a transition to an op-out system.
Recommendation 3
2.85 The committee recommends that the bills be passed.
The Australian Greens were largely supportive save in the area of wanting better access controls and some public health information access.
Australian Greens Recommend
Recommendation 1
1.1 The bill should be clear in section 15 that the ability of consumers to further protect the privacy of their data may be enhanced by the Rules or System Operator.
Recommendation 2
1.2 That section 15 (b) (ii) of the bill be amended to require the System Operator to consult (with the independent advisory council or other community representatives) in the development of default access controls.
Recommendation 3
1.3 That the definition of "healthcare" be amended to include "preventative health".
Recommendation 4
1.4 That the bill be amended to make explicit reference to the use of anonymised, aggregate data from the PCEHR system for research and public health purposes.
The Opposition’s view is pretty clear from the first few paragraphs of the Dissenting Report.

Dissenting Report by Coalition Senators

1.1 The Coalition shares the ambition of health professionals and the Government to develop a quality e-Health system using a Personally Controlled e-Health Record. However we accept the serious and disparate concerns of many witnesses to this inquiry regarding the infrastructure, access controls and governance of the proposed PCEHR and want the introduction of the PCEHR delayed pending major changes.
1.2 There is currently a concerning dissonance between the assurances of the Government and the very real concerns raised by practitioners and experts in the ehealth industry. The Coalition is concerned that the Government's political needs for a "big bang" approach to the introduction of e-health on a given date are being given primacy over common sense.
1.3 The majority of witnesses expressed serious concerns with the process so far and the consequences of the legislation if it were to proceed in its present form and time frame. The four major issues are:
  • the functionality and interoperability of the PCEHR
  • confidence of consumers and clinicians in a proposed e-health system
  • governance and conflicts of interest problems in a system designed to hold the health records of every Australian
  •  risk and patient safety.
These four should be the spine of a quality and safe system.
1.4 Given the Labor Government's track record on program implementation, the Coalition fears that poor implementation and governance will occur leading to yet more waste of taxpayers' funds when the system fails.
1.5 Further evidence about patient and systems safety and about NEHTA's overstatement of delivery was presented to Committee members in the final week of the inquiry. The information will be made public once responses to adverse comments in the evidence have been received. This evidence further deepens the Coalition's concerns about this Government's ability to deliver a functional and safe e-health system.
----- End Extract.
The Coalition also had concerns regarding, access, privacy, timing and liability at the very least.
Here is their conclusion and recommendation.

Conclusion

1.47 That so many fundamental issues are yet to be resolved a little over three months from launch after six years of development and the expenditure of between $467 and $750 million must be a matter of great concern.
Recommendation:
1.48 Coalition senators recommend that the PCEHR legislation be delayed until July 1, 2013, in order to satisfactorily address the many issues raised during this Inquiry, especially those relating to governance, patient risk, privacy and interoperability are resolved.
So there we have it.
It will be fascinating to see what actually now transpires. I wonder might the Minister decide that the best course is to follow both sets of recommendations. Pass the legislation and defer the start while things get sorted out and something can be done to have NEHTA regain the confidence of the Parliament.
We do live in interesting times!
David.

4 comments:

Cris Kerr said...

'Meaningful purpose' and 'meaningful use' should always have been the highest priority for ehealth; but this founding principle has been missing from the very beginning, and I am at a complete loss to understand why so many 'influential' people over such a long period of time have ignored or refused to discuss 'meaningful purpose and use'.

The Greens were the only party to touch on a meaningful purpose for ehealth with their Recommendation 4.

This is what every logical, thinking person would expect of a national ehealth system, that is; the capacity to discreetly and securely collect and use (analyse) the widest range of health information in a meaningful way for the purpose of improving health outcomes for all - to secure a better health future for all Australians - to shore up this nation's economic capacity to continue to provide quality healthcare for all well into the future.

This is critical, so that in Australia's future we are not economically forced to go down the same track as the USA - where responsibility for public healthcare was long ago abandoned and transferred to employer private health insurance schemes - where the unemployed must fend for themselves - they cannot afford to see a doctor, cannot afford tests, cannot afford to fill prescriptions, cannot afford necessary procedures, cannot afford hospital care.

Recent News: 'EHRs should include patient-reported data', National Cancer Institute, Harvard University and the University of North Carolina at Chapel Hill, March 2012: 'Adding The Patient Perspective To Comparative Effectiveness Research', March 2012
http://content.healthaffairs.org/content/29/10/1863.abstract?sid=18618fe7-d37f-45f7-be1b-77306039f54f

Not a single 'influential' person, not a single 'influential' politician, not a single so-called 'influential' consumer representative body has, during this entire period, supported meaningful use or patients' rights to self-report their health outcomes so they can make a meaningful contribution to 'meaningful use'.

My sincere thanks to the Greens for at least raising this:

Greens Recommendation 4:
1.4 That the bill be amended to make explicit reference to the use of anonymised, aggregate data from the PCEHR system for research and public health purposes.
The Opposition’s view is pretty clear from the first few paragraphs of the Dissenting Report.

Anonymous said...

1. We should be disappointed by the "committee" conclusion, which is more or less along the lines of "we have a lot of reservations about NEHTA's ability to deliver this project but the Department has told us that everything is under control so we think the program should go ahead".

2. The coalition senators' recommendation that the legislation be deferred until 1 July 2013 is the only mechanism that they have available to defer Implementation.

Proposed solution:

Go live with a reduced scope PCEHR on 1 July 2012. This could include:

a. Basic Vendor Repository interface (already largely implemented by lead site and GP Vendor Panel vendors)
b. CDA documents without atomic data (CCA Conformance Level 1a), readily supported by participating technology providers and significantly reduces risk associated with automated data interpretation
c. Limited use of the HI Service
d. Alternative sources of PKI certificates (Medicare, other providers)

This would:

• Deliver a low-risk, working solution that provides value to clinicians - on 1 July 2012
• Remove the Coalition's need to vote down the legislation to defer the PCEHR program
• Save the Government from an embarrassing vote against them in the Senate
• Give the Government something positive to launch on 1 July 2012
• Defer all of the risky bits of the PCEHR for 12 months (or less if they can be fixed sooner, or longer if it takes longer)
• Get the HI Service right before it is used on any large scale
• Get the NASH right before it is used at all
• and the same for SNOMED, AMT, Consolidated View, Portals, B2B and the list goes on

Deferring the legislation is an option for the Coalition and the Greens if common sense does not prevail.

Dr Ian Colclough said...

Cris Kerr said 'Meaningful purpose' and 'meaningful use' should always have been the highest priority for ehealth.

Well said Cris. That is why in my Senate Submission I urged that Government stop dilly dallying and support the immediate deployment of the Electronic Transmission of Prescriptions [ETP] as a fundamental step towards effective, reliable, timely and accurate medication management across every health care sector; in short meaningful purpose and meaningful use.

That too is why Deloitte recommended ETP as the highest eHealth application to be implemented without delay.

It beggars belief that DOHA, having agreed with that Recommendation in its response to the Deloitte Report, has, as far as I can tell, done next to nothing of note to bring ETP to fruition.

A few weeks ago the Victorian Coroner pointed to the decade long failure of Government to address the very serious issue of Doctor [Prescription] Shopping. He called for the immediate deployment of online, realtime prescription prescription monitoring in Victoria. That is best example I can find of MEANINGFUL PURPOSE and MEANINGFUL USE.

Cris Kerr, Case Health, Submission No 35 said...

Great PCEHR Inquiry submission Ian.

I particularly liked reading this part;

' ... the PCEHR must be underpinned by the development of a core solution which can be implemented in manageable incremental steps, then embedded to become a routine feature of the daytoday functions of the health system and subsequently scaledup and built upon with confidence. ... '