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Monday, March 19, 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.