Is it safe? Great debate on health IT safety and regulation

The International Society for Quality in Health Care (ISQua) is inviting comments and votes on an online debate on whether health IT is improving the safety of healthcare.

Introduced by David Bates, chief innovation officer at Brigham and Women's Hospital in Boston, and featuring Australian surgeon Guy Maddern speaking for the negative, the debate also queries whether further regulation of the industry would inhibit innovation and make safety worse.

“We have a lot of evidence that health information technology (HIT) does improve safety, at least in selected institutions, but now the HIT that is being implemented is largely vendor developed and it is being implemented much more broadly,” Dr Bates said.

“There have been many reports of new problems that have been created by health information technology.”

Dr Bates said there had also been a substantial amount of discussion about the amount of regulation required, which led to the topic of the debate: HIT is already improving healthcare safety and current regulation around it is sufficient.

Speaking for the proposition were Aziz Sheikh from the Centre for Medical Informatics at the University of Edinburgh, a former GP who is now one of the world's leading evaluators of health IT; and Dean Sittig from the University of Texas School of Biomedical Informatics, who has a specific research interest in the design, development, implementation and evaluation of clinical information systems.

Speaking against was Professor Maddern, who in addition to his roles as a practising surgeon at The Queen Elizabeth Hospital and as professor of surgery at the University of Adelaide, is also the surgical director of the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical for the Royal Australasian College of Surgeons.

He was joined by Ross Koppel, a professor of sociology from the University of Pennsylvania and a senior fellow at the Wharton School’s Leonard Davis Institute for Healthcare Economics.

Professor Sheikh argued that the evidence base points to the fact that HIT can affect safety but in reality, there “isn't an epidemic of harm associated with HIT”. He also argued that regulation can be well-intended but it can also have unintended consequences, including the stifling of innovation.

“I have for a number of years been summarising the international evidence on HIT and its impact on the quality and safety of care, and I'll be the first to admit that whilst there is enormous potential, quite often this is not being realised,” Professor Sheikh said.

“The challenges are largely in relation to limited functionality, it quite often doesn't meet the needs of front-line physicians, there are challenges with usability, there are socio-technical issues about how this can interface with workforce deliberations on clinical workflows.

“This can sometimes lead to professional frustration and lead to poor patient experiences and there are certainly some cases where patients come to harm, but if I reflect from general practice in the UK for example, where we have been digital for the last at least 15 years … there is no large-scale evidence of any epidemic of HIT-associated, iatrogenic harm.”

He argued that there was already a raft of legislative and regulatory approaches in the UK, the EU and the US, all of which are designed to enhance the safety of HIT devices or software, and that regulation quite often has unintended consequences such as stifling innovation.

“If innovation is stifled, if the regulatory bar is so high that new entrants can't enter into the marketplace, what this will do is it will really stifle competition,” he said. “What we actually need at this point in time is that we need new entrants, we need more dynamism in the vendor marketplace, what we need is competition because what this will do is it will force innovations in new directions.”

Professor Koppel countered by saying that while HIT continues to hold immense promise for reducing medical errors and collecting instant and vast data, clinicians find this technology frustrating and falling short of its promised benefits.

Professor Sittig argued for the proposition, saying the fact that HIT is already improving patient safety should be abundantly clear to anyone who can even remotely remember what healthcare was like in the pre-computer age.

With the recent advances in technology, our newly acquired capability to measure and monitor various aspects of medical care has already had a significant positive impact on the safety of healthcare and this will only increase as we learn more about how to collect and interpret these large databases, he said.

He also argued that current regulation is sufficient and that there is a risk to patient safety due to our limited understanding of any unintended consequences that might arise due to inappropriate additional legislation.

Speaking last, Professor Maddern said that as a clinician, he constantly has to wrestle with the realities of dealing with IT systems.

“At present, many hospital systems, certainly outside of North America, are still using paper-based systems,” he said. “One has to ask oneself why this is the case, given that we are all very used to having smartphones, computers in our offices and navigation systems in our cars.

“Why is it that the health sector has been so slow to embrace the electronic health record and the promise that it brings?”

He argued that despite companies spending billions of dollars trying to develop electronic health records and IT systems, they have largely been developed by “computer geniuses” without much reference to the doctors, nurses and allied health professionals who are going to have to use the technology.

“For this reason, the capabilities of many of the systems is extraordinary but the usability is anything but remarkable,” he said.

He used the example of Australia's PCEHR, which while it may have millions of people enrolled it only contains records numbering in the tens of thousands, not the hundreds of thousands or millions.

He argued that there was tremendous support given to GPs to use the PCEHR but nothing to specialists or the hospital sector.

“In a country like Australia where particularly as people get older, they travel quite large distances, the ability to have a portable record is obvious,” he said. “The reality however is that this is largely unused and I would have to say in my own hospital, I would not have any idea how we would access it despite the fact that I know it's available.”

He argued that digitising and storing health records was an obvious enticement to hackers, and that the use of electronic health records in practice could and does interfere with the doctor-patient relationship.

He also argued that many hospital-based EHRs were built for accounting rather than care delivery reasons, and regulation was absolutely essential if we are going to be able to maintain sensible control of the data generated.

“No doubt the next decade will see these technologies become widespread but at the moment they are at best primitive, unhelpful and poorly developed.”

Posted in Australian eHealth


0 # Scot Silverstein 2015-07-31 04:12
> Professor Sittig argued for the proposition, saying the fact that HIT is already improving patient safety should be abundantly clear to anyone who can even remotely remember what healthcare was like in the pre-computer age.

I remember very well - remember, that is, what is was like to not have to deal with computer mayhem and to pick up the phone regarding the occasional illegible note (now we have to deal with reams of legible medical gibberish).

What is the EHR-related harm rate? Uh - we don't know. Nobody does. Infrastructure not in place to collect data and know, much evidence never surfaces, what we know is the tip of the iceberg (FDA's Dr. Shuren). We do have this, though:

But it is ABUNDANTLY clear that EHRs improve safety. You hear that? ABUNDANTLY CLEAR.

That's what passes science in this field.


See my collection of issues on this topic at "FDA on health IT risk: "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (

Scot Silverstein, MD
0 # Cris Kerr 2015-07-31 07:53

A patient's eHealth record should capture and present summarised high quality data in a structured, logical format and sequence, such that every clinician is presented with a user-friendly patient health history summary with a high degree of reliability on every occasion a record is accessed (where data is refreshed/updat ed and drawn into the summary on every access occasion).

Summarised data within the patient's record should, of course, readily link to all related information (events, xrays, etc).

An eHealth record in and of itself is simply an organised filing system underpinning an organised presentation of raw data.

Hence, an eHealth record has no need to be creative or innovative.

It is simply an electronic version of a paper record given steroids.

In essence, it has the same fundamental purpose it's always had - capturing and presenting raw, clinically useful data of the highest integrity.

This debate, therefore; is really about what happens after that raw data has been captured - so we're really talking about secondary uses for patient health data.

When people promote 'creative or innovative' in direct relationship to patients' electronic health records, it gives me chills down my spine.

The only legitimate secondary use for patient health data is health and medical research, and clearly (without question) that needs to be done within a highly regulated environment.

For these reasons, it is clear that all raw data should be securely captured, stored, and protected within a single, tightly-regulat ed system and environment chartered and legislated, with a clearly articulated health and medical research purpose (primary or secondary use).

I certainly wouldn't want my own family's health data captured and employed in a wild west, unregulated environment, where commercial organisations are given free reign over the 'creative or innovative' storage and use of patient health data - and nor should you.

NB - PCEHR: Few understand how the PCEHR system was initially developed - national health data is captured and stored, but it is not captured and stored within a single data repository. The data is captured within a number of national health data repositories (eg national hospital data, pathology data, etc). When a patient's eHealth record is accessed via a patient's individually allocated PCEHR number (an individual healthcare identifier is used, not the patient's name) - up-to-date data from all repositories is drawn into that patient's eHealth record. This is a far more private and secure system than say, your local doctor's electronic health record system.

Online Debate Link:

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