The Opt-Out Trials May Be Much Trickier That Is Presently Believed. There Are Many Challenges I Suspect.

The latest news on the plans for the trials comes from Senate Estimates a week or so ago..

Here are the relevant bits (Skip down a page or so if you have already read it all)

Senator MOORE: What consultation has been had with the medical profession regarding the decision to shift to the opt-out system?

Mr Madden: The recommendations from the review were to increase participation in the system. The health community had said, 'If we had the majority of our patients in the system, we would be more compelled and likely to take this on and use it.' That came through in the form of submissions from the AMA, RACGP, Consumers Health Forum and others—

Senator MOORE: That was prior to 2014.

Mr Madden: That was in 2014, in the report. We did do some consultation directly with health care providers and the community between July and September 2014 just to confirm views about how that would work. The point I need to make is that opt-out, in the current budgetary decision, is to trial opt-out in at least two geographical locations to understand the issues and make sure that we have continued to maintain the consumer's or individual's confidence in the system and to understand the issues that might come with that. So we have not taken a decision to move completely to a national—

Senator MOORE: But you have made a decision to go to the trial of two opt-outs, which is a distinct change from the other process. This committee did an inquiry into the original legislation and the opt-in/opt-out model was a great point of contention at that time. So now, as a result of the review, we have gone with a trialling of opt-out.

Mr Madden: Yes.

Senator MOORE: What form are the trials going to take; has that been determined?

Mr Madden: We are looking at least at two trial sites. We are working with states and territories through the Australian Health Ministers Advisory Committee on the possible selection of sites. We need to find sites which are discernible so that people who are in the sites in the trials know that they are in the trials and people who are outside know that they are clearly not. So we will be doing consultation on the location of the trials. We will be trialling our communication processes and also working through education, communication and training for GPs and other health care providers in the trial sites. While the population and the individuals in those areas might have a registration, we want to make sure that the health care providers are engaged with that system as well. That is why it is important to work with the states, so that we have a connection through the public hospital system.

Senator McLUCAS: Are you proposing to use a PHN boundary for those trial sites?

Mr Madden: Not necessarily. The trial population that we are looking for across, again, a minimum of two and a maximum of five, would be about a million people. So it would probably be an amalgam of some PHNs and it could be based on postcodes that join a couple of PHNs together. We want to get a spread that includes lots of people or individuals and lots of GPs and specialists, allied and private, and public hospitals to get the whole connected community of health care providers for that community involved.

Senator MOORE: Have the terms of the trial been determined yet?

Mr Madden: No. Where we have got to at the moment is to describe the criteria that would pick out what those trial areas might be. We will be looking to appoint an independent person to create the evaluation criteria for that, certainly well before the trials begin.

And here:

Senator MOORE: I was just talking with you, Mr Madden, and also with NEHTA about the opt-out trials and in terms of the process you said you were going to look at two sites. Is that right?

Mr Madden: Yes. We are looking for a minimum of two sites. We do not want to go any larger than five. Again, we have criteria that would describe what would make for the best sites or not for the best sites. Did you want to know about the logistics of the opt-out?

Senator MOORE: Yes, I do, because of the process.

Mr Madden: By September we are looking to have the sites selected. In the funding for the opt-out trials or what we have called the participation trials, we have funding for education, communication and training for healthcare providers and certainly a heavy dose of communication for individuals in the areas so they are aware of what this means to them, what they get as a benefit, what their rights are and what they do if they choose to opt out. We would be looking to do that from early 2016 with the training starting around about the same time for the healthcare providers.

We then have a period for two months where we have a system available for the communities to inquire and get information about staying in the system or opting out of the system. They will have a system where they can indicate their expectation or their option to opt out of the system and after that two months we will create skeleton eHealth records for all of those people who did not choose to opt out. We will then give them six weeks or so for them to log into and take control of their records, if that is what they choose to do, because the eHealth system will still have the patient or the personally control aspects. They can still determine who can operate their eHealth record on their behalf, healthcare providers that might be allowed to or not allowed to upload records to their record and who can or cannot see particular records. They will have five weeks to take control of those and to put all of those controls in place if that is what they choose to do. Then about two weeks after that we will create the records. We are looking to target that for having records in the hands of healthcare providers and individuals after the controls have been set some time during July 2016.

Senator MOORE: So it is just over the year?

----- End extract.

So, in summary, after site selection we will have:

1. Education of providers and consumers on what is happening, what their rights will be to opt-out starting in early 2016 - with some training for providers in early 2016.

2. Two months will then be spent with consumers being able to try the system and inquire about and choose to opt-out etc.

3. Then everyone who did not opt out will have a skeleton record created within the system - presumably using data from the IHI service.

4. The opted in consumers will then have five weeks to take control of their record and set their desired access controls.

5. Two weeks after that the record will be populated with all the other information like, presumably PBS and Medicare claims data.

6. Providers and users will then have access and the system will be available for use a little over a year from now. Of course there will still be limited numbers of Shared Health Summaries and other useful clinical documents.

At present we do not seem to have information on:

1. How long the trials will actually run? - it would need to be a reasonable while - at least a year in my view.

2. Just how the trials will ensure the consumers (and providers) are actually engaged with all this - we are, remember, talking about a million people - many of whom will be children, homeless, lacking literacy or internet access, be mentally impaired or incompetent, be just who just ignore Government messages etc. (is no response treated as agreement to have a record or not?).

3. What the evaluation criteria for the Trials will be and how the trial outcomes will inform what happens next?

4. How will those who move in or out of a geographic trial area be detected and informed what is to happen to them and what they need to do?

5. How will those who reach an age of competence for independent decision making be alerted that they need to take some decisions and how will children who desire independence from parental access to their record be managed?

6. How will children who do not have control of their record and who want to suppress information (medications, referrals etc. that has been automatically loaded) from parents and others and who are old enough to know what they are doing, obtain the control they want of their record?

7. How will it be determined who controls an opt-out record if the patient is for some reason not able to take control for themselves?

8. What will happen if a disengaged consumer has information automatically loaded into the PCEHR they are concerned about being known to others and this information is then disclosed via clinician access to the record (or more likely their staff)?

9. How will control of created PCEHRs be adjusted in the event of divorce, family violence etc?

Feel free to add further concerns of your own regarding the trials. I am sure there are many others.

I have to say to have an unconsented record created and populated for you when you are a demented 90 year old in a nursing home or a fifteen year old who wants nothing to do with her abusive parents having access to her auto-created record seems pretty bizarre. Surely we need to have a positive response agreeing to opt in before record are created? If not the Government is setting itself for a ‘world of pain’ I reckon. I wonder has this been properly thought through?

David.