Sunday, April 15, 2012

The Australasian College Of Health Informatics (ACHI) and Others Weigh In On NEHRS Regulations. This Area Is Becoming Quite Controversial and Messy.

Last  week submissions on the Rules and Regulations covering the NEHRS (PCEHR) were due.
Here is the background.

PCEHR System Regulations and Rules

The PCEHR System: Proposals for Regulations and Rules describes the proposed regulations and rules which will be put in place to support the national personally controlled electronic health record (PCEHR) system and the legislation which is currently before Parliament. The Personally Controlled Electronic Health Records Bill 2011 (PCEHR Bill) and Personally Controlled Electronic Health Records (Consequential Amendments) Bill 2011 (Consequential Bill) were introduced into the Parliament on Wednesday 23 November 2011.
The paper has been developed by the Commonwealth in consultation with a working group of representatives from Commonwealth, state and territory health departments. It takes account of feedback and submissions received by the Department of Health and Ageing during the public consultation processes for the PCEHR system.
The PCEHR System: Proposals for Regulations and Rules describes the provisions that are proposed to be included in the regulations and rules, explains the reasons behind those proposals and describes how they are intended to operate.
You can find out more about the paper by reading the frequently asked questions.
The paper is intended to promote discussion within the community about how well the proposed regulations and rules would operate in conjunction with the PCEHR Bill and Consequential Bill, and support the PCEHR system.
The period for making comments and submissions on the PCEHR System: Proposals for Regulations and Rules closed at 5 pm on Wednesday, 11 April 2012.
Here is the link to the page:
Earlier I commented here:
and later here:
where the is some extra input on the issues provided
With the deadline for submissions due we have seen some reaction.

GPs face 'extreme obligations' with e-health

12 April, 2012 Sarah Colyer
GPs would be forced to open up their practices and hand over records to health department investigators under draft powers to police the national electronic health records system.
The conditions, circulated for comment this month, would be mandatory for any practice wanting to take part in the personally controlled electronic health records (PCEHR) scheme due to commence on July 1.
The success of the system is dependent on GPs agreeing to create and manage patient health summaries on the records.
But the AMA has warned that the conditions create such "extraordinary obligations" that they would deter every medical practice in Australia from taking part.
This is on top of the apparent lack of financial support for curating the records.
More here:
There is also some reporting Government may have backed off.

Health department reversal on PCEHR liability

12th Apr 2012
The health department will rewrite the “unfair” conditions of registration for the personally controlled e-health records (PCEHR) system which required practices to assume all liability and grant unrestricted access to premises and records.
The draft conditions were panned by health insurers and industry experts after MO last week broke the news that the AMA had warned the health department that the “unfair” requirements would “deter every medical practice in Australia from participating”.
MDA National president Associate Professor Julian Rait said any lawyer would say the condition requiring access to a practice’s premises, IT systems, records and staff was “a dealbreaker”.
More here:
We have also had a submission from ACHI.
Here are the recommendations:
----- Begin Extract
In summary, there are a number of areas where the College believes clarification and improvements are required and has formulated 13 recommendations for the Department's consideration, namely that:
Recommendation 1:  further time be allowed for consultation on the PCEHR Regulations and Rules in advance of the passage of the draft legislation currently before Parliament.
Recommendation 2:  the PCEHR Regulations and Rules provide policy guidance to the system operator by setting the terms and conditions for technical access to the PCEHR system.
Recommendation 3:  the PCEHR Regulations and Rules should consider mechanisms to provide medico-legal protection for users acting in good faith to accepted clinical standards.
Recommendation 4:  the relationship between the Jurisdictional Advisory Committee (JAC) and the Independent Advisory Council (IAC), and their respective roles, be further clarified in consultation with stakeholders, including ACHI.
Recommendation 5:  the PCEHR Regulations and Rules provide further detail with respect to privacy and security and the management and control of audit trails.
Recommendation 6:  the concept of “a minimum data set for PCEHRs” be removed from the document.
Recommendation 7:   in addition to consultation with the JAC, the Minister be required to consult  with the IAC prior to making Rules under the PCEHR legislation.
Recommendation 8:  DoHA consider initiating action to establish the Independent Advisory Council in advance of the legislation coming into effect as soon as practicable.
Recommendation 9:  the Rules described in relation to access controls within healthcare provider organisations be substantially revised to take account of existing practice and legislation.
Recommendation 10:  the system operator and DoHA assure themselves, through testing, that the identification of consumers wishing to access the PCEHR is fully fit for purpose and meets consumer expectations.
Recommendation 11:  the Rules provide further clarity on the concept of document authors/authorisers and their obligations with respect to uploading to the PCEHR.
Recommendation 12:   the Rules dealing with risk mitigation for gaining participation take account of the scale and complexity of the provider organisation.
Recommendation 13:  the Rules dealing with risk mitigation emphasise the critical nature of encrypting all PCEHR data.
----- End Extract.
The full document is found here:
Interestingly there does not seem to be many other submissions yet on line from people like the AMA, RACGP and so on.
The Australian Privacy Foundation has a lot to say here:
I do however note that AVANT - a major Medical Defence Organisation - is running webinars on the NEHRS - warning clinicians about the risks.
See here:
While very much supporting what is being said by the various spokespeople and ACHI I am getting the feeling that in the rush for July 1 implementation date there may not be much notice taken of some pretty serious concerns.
I guess we will have to wait and see if another draft, or even possibly some actual regulations become available in due course.
It is clear there will need to be a great deal more work and consultation done to have many of the medical profession touch this system - which I have to say is looking more and more like strategic overreach as every day passes.
This whole thing could certainly do with less haste and more speed.

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