Is this the e-health breakthrough we’ve been waiting for?

Bill Gates once said “your most unhappy customers are your greatest source of learning”.

It seems the Australian Government has understood this message, as it is now considering major legislative changes to the personally controlled electronic health record (PCEHR) system.

This is good news. Doctors and patients are often confused about the rules regarding the collection, use and disclosure of information on a PCEHR.

An example of ambiguities includes doctors being advised not to use PCEHR data when providing third-party reports. But what happens to PCEHR information that, over time, has been incorporated in local databases? And are doctors allowed to access a PCEHR in the patient’s absence?

What’s the purpose?

This lack of clarity reflects a bigger problem — the absence of a clearly articulated and shared goal underpinning the national e-health system.

In the absence of an agreed purpose, rules and systems can become arbitrary or misguided, restrictive and lacking in consistency. Doctors, patients and policymakers first need to agree on the main purpose of the PCEHR.

Ultimately it is a tool intended to improve the provision of care: patients disclose their personal data to doctors and, in return, receive more effective and personalised care. I would be happy if the data were used for other purposes such as disease surveillance or even feedback on my clinical management but, in the end, it is the patient’s record and they must have a say in it.

Proper consent

A proper consent procedure is essential for any use of PCEHR data outside individual patient care. It appears the PCEHR system operator is currently authorised to collect information in individual PCEHRs for law enforcement, health provider indemnity insurance cover, research and public health purposes, and as required or authorised by law.

This should be more transparent with a better explanation of what it means for both patients and clinicians.
Patients should also understand the pros and cons of setting advanced access controls, especially now an opt-out system is on the cards. Adequate support will be required for specific groups including the elderly, people with a disability or mental illness, and some 14–17-year-olds.

The right to be forgotten

At the moment, PCEHR data are required to be held for up to 130 years. An interesting concept to consider is the “right to be forgotten”, which has been introduced in the European Union Court of Justice to give people the right to remove data from search engines under specific circumstances.

This concept is applicable to e-health. Patients, for example those with a mental health diagnosis early in life, may want to have part or all of their PCEHR record erased at some point (not just deactivated) to avoid stigmatisation or other repercussions — rather like the expunging of juvenile criminal records to give young people a fresh start.

Liabilities & incentives

Removing the need for participation agreements seems like a good idea. The Department of Health proposes that the liability provisions in the agreements be disposed of, rather than transferred to the legislation.

It is unclear what this would mean for the liability of doctors and health care organisations.

It seems new incentives will be paid to doctors who upload records to the PCEHR on behalf of patients with care plans. Although this will be welcomed by most doctors, it excludes other patients who don’t have a care plan but who would also benefit from a PCEHR.

Linking payments for chronic disease management to the uploading of documents is complicated. If it is introduced without other improvements to the PCEHR system, it could create more resentment among doctors and may lead to poor-quality uploads

What happens if patients do opt out of the PCEHR? Will their doctors be paid less to look after them?

And what if a patient who would benefit from a PCEHR declines to have a care plan, or the doctor provides chronic care without creating care plan documents or health assessments? In that case, there would be no incentive for the doctor to upload data to the PCEHR.

An upload incentive across the board would avoid these issues.

More criminal penalties?

The government is also considering introducing more criminal penalties, including jail terms, additional to the monetary civil penalties that already exist for data breaches. If we want to increase participation and engagement by doctors, I’m not sure that more penalties will help.

The challenge is to make e-health an integral part of health care, and align its purposes and values with usual clinical practice.

Training & education

Astronomer Carl Sagan said: “We live in a society exquisitely dependent on science and technology, in which hardly anyone knows anything about science and technology.” If e-health is to succeed we need to invest in information and communication technology skills. We must train the next generation of e-health designers, builders, managers and users to ensure our e-health system is safe and effective.

This article has previously been published in MJA InsightMany thanks to Ms Jen Morris, Dr Karen Price and Dr Michael Tam for their valuable feedback and suggestions on the draft of this article.

Rebooting the PCEHR: Opt-out and a new name are not enough

Health Minister Sussan Ley has announced that “the Abbott Government will deliver a rebooted personalised myHealth Record system for patients and doctors that will trial an opt-out, rather than opt-in, option as part of a $485 million budget rescue package (…).”

I like the word ‘rebooted’, as it implies a fresh start and that is certainly what the Australian e-health records system needs. ‘MyHealth record’ sounds better than PCEHR too. But many questions remain, including the most important one: will clinicians use the renamed system once it’s opt-out instead of opt-in?

The legal stuff

Clinicians have concerns that have not yet been addressed.

For example, at the moment the information in the PCEHR may be used by the Government for data mining, law enforcement purposes and ‘other purposes authorised by law’, for up to 130 years, even after a patient or provider has opted out.

When healthcare organisations or practices cancel the PCEHR participation agreement, seven of the fourteen clauses survive termination, including liability of providers.

Other concerns are that the Minister of Health may make or change PCEHR rules without legislation and the Department of Health can change the participation agreement at any time without the need for input from doctors or patients.

Improvements

If the Health Minister is serious about engaging clinicians, here are some of the issues that must be resolved:

  • The purpose of the PCEHR (myHealth Record) must be clear
  • The legal framework should be reviewed, and any changes must be agreed upon by consumers and clinicians
  • If consumers want to opt out at any stage, they should have the option to have their data removed from the system
  • If providers opt out at any stage, their liability should end as well.

And that’s just the beginning. Here’s to hoping that the $485 million will be spent wisely.

The PCEHR: Moving forward

I can confirm that the Government is not going to build a massive data repository. We don’t believe it would deliver any additional benefits to clinicians or patients – and it creates unnecessary risks (~Nicola Roxon)

I’ve studied the PCEHR but I’m still not sure what the government has built and for what purposes. I was always under the impression that the PCEHR was designed to assist clinicians to improve patient care through better data flow. But this may not be the case.

The recent resignation of NEHTA’s top National Clinical Leads is an ominous sign. If the Department of Health does not start sharing ownership of the PCEHR soon and improve governance of the system, the PCEHR will fail. Here’s a quick rundown of the issues and how to move forward.

Legal issues

A first glance at the PCEHR Act 2012 seems to confirm that the PCEHR is built with clinicians in mind, as its four purposes are clinical in nature:

  • To help overcome fragmentation of health information
  • To improve the availability and quality of health information
  • To reduce the occurrence of adverse medical events and the duplication of treatment
  • To improve the coordination and quality of healthcare provided to consumers by different healthcare providers

So far so good. But the Act is 93 pages long and I could find at least five other ‘non-official’ purposes of the PCEHR spread out throughout the Act:

  • Law enforcement purposes
  • Health provider indemnity insurance cover purposes
  • Research
  • Public health purposes
  • Other purposes authorised by law

And this is where the concerns begin. These ‘non-official’ purposes are not directly related to the care doctors provide to their patients. In general, one would say that patients and clinicians have to give informed consent before their health information can be used for research or other purposes. It seems informed consent is missing here.

Contractual flaws

Combine this with certain clauses in the one-sided PCEHR participation agreement and you’ll forgive me for thinking that the government, contrary to Roxon’s reassuring words, has built a massive data repository:  Once clinicians sign the agreement, they grant the Department of Health and Ageing a perpetual, irrevocable, royalty-free and license-fee free, worldwide, non-exclusive license (including a right to sub-license) to use all material they have uploaded to the PCEHR.

Those who think that you can always opt out are mistaken. Even if health care organisations or practices cancel the participation agreement, seven of the fourteen clauses survive termination, including clauses regarding liability. It is good to know that the government will continue to use the information after cancellation by a clinician or consumer for up to 130 years.

Another concern is the fact that the Minister may make or change PCEHR rules without legislation, and the Department of Health can change the participation agreement at any time without the need for input from clinicians. We thought the After-Hours and PIP contracts by Medicare Locals were a disaster, but this agreement is possibly worse.

Other problems

By now it is obvious that Clinical Leads and professional organisations have not been involved in many important decisions. There is a range of other issues, which I won’t discuss here in detail, including technical software glitches and the absence of MBS item numbers. Under the PCEHR Act 2012, all clinicians are appear to be seen as employees, which could be a problem as many doctors may be employed as contractors for various reasons.

Moving forward

If the PCEHR can be used for data mining, legal purposes, insurance purposes etc, then that is fine, but, I would strongly advise the profession to stay clear from it. If however we agree, that the PCEHR is a clinical tool, then clinicians must be involved.

What we need first of all is an open, well-informed discussion about the purposes of the PCEHR. What are consumers and clinicians exactly saying yes to when they sign up? A proper, transparent, independent governance structure with specific executive authority should be formed. This PCEHR Board should include members from professional and consumer organisations and act as a watchdog over the PCEHR. Any changes to the rules require a consultative process with professional bodies including AMA and RACGP before the Board can sign off. The current PCEHR Advisory Committee and Council are not fulfilling these criteria at the moment.

Consumers should know exactly what happens with their data after they have visited a health care professional and who has access to their information. The purposes of the PCEHR must be clear and agreed upon by all stakeholders. Clinicians own the rights of the data they create and upload, there is no need to grant the government a perpetual irrevocable license to use this data.

The PCEHR Act 2012 and the participation contract must both be reviewed and made 100% acceptable to clinicians and 100% opt-out must be possible for clinicians and consumers at all times.

This will take time, but if we don’t start now there is no hope for the PCEHR.

This article has been published in Medicus, the journal of the AMA(WA)