Quote Of The Year

Timeless Quotes - Sadly The Late Paul Shetler - "Its not Your Health Record it's a Government Record Of Your Health Information"

or

H. L. Mencken - "For every complex problem there is an answer that is clear, simple, and wrong."

Thursday, July 17, 2008

E-Prescribing Gets a Huge Boost in the US.

This week we have had some very good news about the use of e-Prescribing.

Congress Passes Medicare Bill with Veto Proof Margin

After multiple unsuccessful attempts in June to pass a Medicare bill, on July 9th the Congress passed the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331), which prevents a scheduled 10.6% cut to Medicare payments to physicians, and includes financial incentives to accelerate the use of electronic prescribing by physicians, among other things. Not only did both houses of Congress pass the measure, but they also passed it by a veto-proof margin, so even if President Bush refuses to sign, Congress could still force the measure through. The Senate voted 69-30 to approve the bill, while the House voted 355-59.

In addition to addressing the annual need to offset the Medicare Sustainable Growth Rate (SGR) cuts, the Medicare Improvement for Patients and Providers Act will provide positive Medicare payment incentives of up to 2% for practitioners who use qualified e-prescribing systems in 2009 through 2013, and a reduction in payments of up to 2% to providers who fail to e-prescribe by 2012. The bill permits the Secretary to establish a hardship exception to providers who are unable to use a qualified e-prescribing system. The bill also calls for a Government Accountability Office (GAO) report on the effect of the e-prescribing incentives included in the legislation.

More here:

http://www.himss.org/ASP/ContentRedirector.asp?ContentId=68157&type=HIMSSNewsItem

This is really good news as the legislation has a neat mix of carrot – extra pay and stick – a financial penalty – to really encourage adoption and use – while providing a sufficient period of time to allow prescribers to get used to the idea.

More important is that this move is the ‘thin end of the wedge’ in getting US physicians to start using computers. This will hopefully flow on to the use of more EHR functions over time with the benefits that will flow from that.

Best news is that President Bush can’t veto the legislation. If he does not sign – it becomes law in 10 days anyway because of the 2/3 majority obtained in both Congress and the Senate.

I wonder what cool functionality will not emerge to assist docs prescribing with a market of this size to compete for!

David.

Wednesday, July 16, 2008

AusHealth IT at 500 Posts.

Late last week the blog passed the 500 post milestone. I thought that would be a good point to provide some feedback on usage, popular articles etc.

First site usage:

VISITS

Total - 50,357

Average Per Day - 115

Average Visit Length - 1:59 mins

Last Hour - 4

Today - 22

This Week - 805

PAGE VIEWS

Total - 81,541

Average Per Day - 130

Average Per Visit 1.4

Last Hour - 4

Today - 30

This Week - 913

ARTICLE READS

Top 5 Ever.

1. An Invaluable Reference on Health IT Value - 822 Reads

2. Well, Now What is Needed in Australian e-Health is Confirmed – So Let’s Roll - 471 Reads

3. MicroSoft’s HealthVault – Is it Applicable to, and will it work in Australia - 393 Reads

4. The Australian Broadcasting Commission - 362 Reads

5. It is a Dangerous World Out There! 257 – Reads

For the last month (30 days) they have been.

1. What is Big Blue Up to in E-Health in OZ? - 210 Reads

2. Just Why are NEHTA’s Plans for the Shared EHR a Secret? - 185 Reads

3. NEHTA Just Steams On Regardless! - 176 Reads

4. NEHTA Exposes What it Is Up To – By Accident! -172 Reads

5. Could NEHTA Have Been Done Better and Cheaper - 168 Reads

E-MAIL ALERTS

The e-mail alert now goes to 148 different subscribers and total RSS and e-mail subscribers seems to be about 260 - 280.

A few bits of blog news are the following:

1. The blog is now available by RSS feed at www.hisa.com.au

2. The number of comments on controversial posts has now reached a critical mass where I think we are getting some good feedback. I really like this aspect of the blog and it certainly keeps me honest!

Thanks to all for this so far! I can’t promise to make it to 1000..I will probably have died by then (of exhaustion if nothing else) – but I hope I am around to see some real progress!

David.

Tuesday, July 15, 2008

Others Are Noticing the Australian E-Health Mess.

There is always the risk – when typing away in the ivory tower – that one can become a little out of touch. I have thus found it very re-assuring that increasingly other observers are noticing the mess we seem to be making of e-Health.

A couple of examples.

Ready, set… slow

Friday, 11 July 2008

What’s the hold-up on a national, linked electronic health system? Kathryn Eccles finds out.

BEING called to hospital at 2 am to assess a patient with chest pain is part of an average week for Dr Peter Rischbieth.

At his most recent early morning call-out, the RDAA president would have been forced to rely on a 73-year-old patient and her relatives for a medical history were it not for his computerised practice. But a few clicks of the mouse were all that was needed to compare the patient’s current ECG with one from a month earlier.

The comparison showed Dr Rischbieth the ECG was normal for that patient, saving her an 80 km journey to Adelaide, an $800 ambulance bill, the cost of a back-up ambulance crew to provide cover, and time waiting in casualty.

E-health, even at its most basic level – allowing doctors to access patient notes from the local hospital – is not only proving cost effective, it is also saving time and lives.

Research shows that computerised prescribing systems can significantly lower medication mistakes and adverse drug events. And, given that about one in 10 general practice patients experiences an adverse drug reaction over a six-month period (MJA 2006;184:321-24), the potential to make a difference is huge.

This is why progressing the e-health agenda across the country is crucial, says Dr Rischbieth.

…..

And, for many doctors, this lack of symmetry is where the frustration lies. Patience is wearing thin among GPs who have been waiting what seems like an eternity for a functional national system to develop.

They want to see a system that can provide crucial medical details at the touch of a button, that allows professionals to ‘talk’ to each other via secure messaging; to write and process prescriptions electronically; and to scrap the clutter of paperwork.

While all of this does happen to an extent in some areas at a local level, national progress could be described as glacial.

Original plans to introduce a national shared electronic health record were based on a 2010 timeframe.

But that now looks unlikely, with 2012 looking like a more realistic, but still challenging, goal.

Groups in charge of driving the process include the National E-Health Transition Authority (NEHTA), which has been entrusted by the Council of Australian Governments (COAG) to develop standards for the seamless delivery of e-health across every state and territory.

Consultancy firm Deloitte Touche Tohmatsu has been handed $1.3 million by COAG to prepare a national e-health strategy, due later this year.

Former chair of the now-defunct General Practice Computing Group Dr Ron Tomlins believes the extended timescale is simply because NEHTA has “picked the pineapple up by the wrong end”.

“They should be focusing on resources that people already have and encouraging them to use them better and more appropriately rather than search for some... magic solution.”

More here (if you have access to Medical Observer)

http://www.medicalobserver.com.au/medical-observer/news/Article.aspx/Ready,-set%E2%80%A6-slow-

Equally we have the following from another source.

Government dragging the e-health chain in Australia

10 July 2008

Excerpted from a special report I wrote for this week’s Australian Doctor

Jim Clark was known as Silicon Valley’s $3 billion man: the first person to start up three companies that were each capitalised at $1 billion or more. Starting in the 1980s with Silicon Graphics, a pioneer of film and CGI animation, he grew bored with that and helped found Netscape, which launched the world’s first widely used web browser, in the early 1990s.

…..

Clark had the right idea, but back in the last decade he was too far ahead of the curve to make it work. Now, however, e-health is an idea whose time has come.

“E-health is an idea whose time has not only come, it is overdue,” says Associate Professor Ron Tomlins, associate professor of general practice at the University of Sydney, who spent several years as chairman of the General Practice Computing Group.

Professor Tomlins said government and professional initiatives in Australia over the past 10 years that put computers, powerful software and broadband in practices have prepared a foundation that will enable GPs to harness the new online technologies that have been developing independently over the same period.

As more and more doctors turn to the Internet as a professional information source, more than 80% now report that the Internet is essential to their practice, according to research in the US by Manhattan Research. Consumers today, meanwhile, get more health information from the Internet than from their doctors, according to market research firm iCrossing.In Australia, trials of electronic health records and other online applications are under way in most states (see Case studies), while the Federal Government tries to set standards through the National E-Health Transition Authority (NEHTA) to ensure consistency, portability and security of records.

In Canada, the government has set a target of 50% of the population to have electronic personal health records by the end of 2009. In Australia, meanwhile, the government is “dragging the chain”, according to Professor Tomlins, with NEHTA recently announcing that it would be another 10 years before personal health records were in established use in Australia. Professor Tomlins said NEHTA is not moving fast enough, pointing out that it underspent its budget by almost $40 million last financial year.

“General practice is frustrated as hell in the lack of interest from the Commonwealth,” Professor Tomlins said. “The state governments are moving things along with projects such as Healthelink in NSW, SHER [shared electronic health records] and secure messaging projects in the Northern Territory and chronic health management programs in South Australia. But there’s a real danger that they won’t be interoperable and we will end up with a rail gauge situation.”

But regardless of that danger, Professor Tomlins says, the increase in data available to GPs puts them in a good position to use new technologies to improve patient care. “GPs have spent the past few years building up electronic databases for their practices,” according to Professor Tomlins. “Tools are now available to use that data to better understand how better care can be delivered to their patients. They can conduct clinical audits to mine that data, both clinical and financial, and benchmark themselves against other practices to find ways to improve the way care is delivered.

More here

http://wellingdigital.com.au/2008/07/10/government-dragging-the-e-health-chain-in-australia/

All I can add is that the time for messing around should be close to past. We have the Deloittes National E-Health Strategy due in 6-7 weeks and hopefully after that is released (and that it is will be a bit of a test given it can hardly be flattering) we will have a platform for discussion to move the agenda forward.

One hope is that I am hearing from a range of sources that the NEHTA Acting CEO is making a difference! – If this turns out to be sustained it is a very good development. If you read Andrew – and I know your staff do – keep it up!

I sure hope so!

David.

Monday, July 14, 2008

NEHTA’s Clinical Briefing Papers for Your Reading Pleasure.

Some will be aware that in the last month or so NEHTA has been running a range of sessions to brief clinicians on its plans for Health Identifiers and the Individual EHR.

As many will be aware for some reason the Health Informatics Community was not represented at these briefings.

For this reason I thought it would be a good idea to let the readership of the blog see some of what was presented and discussed

Please download the information from this link.

http://www.moreassoc.com.au/downloads/NEHTA eHealth Summit.zip

There seems to me to be a good deal more detail on all sorts of things than we have seen to date, and certainly NEHTA has updated the house documentation style dramatically.

I would really love views (as comments on the blog) from Health Informatics professionals on the plans outlined here. NEHTA still seems to think it can speak ‘ex-cathedra’ rather than getting expert comment before asking clinicians and the public what they think.

I can’t see any restrictions on these documents so I think it is good to have them more widely distributed.

Anyway NEHTA is a publicly owned company and we own them so we are entitled to know just what it is they are up to! – Unless there is financial risk to the Commonwealth – and there is not -they have no right to be so secretive.

Enjoy!

David.

Sunday, July 13, 2008

Useful and Interesting Health IT Links from the Last Week – 13/07/2008

Again, in the last week, I have come across a few reports and news items which are worth passing on.

These include first:

Public leery of electronic health-record security

By: Joseph Conn / HITS staff writer

Story posted: July 8, 2008 - 5:59 am EDT

There are three key take-aways from a recent survey on the scope of the healthcare data-security problem.

Only one of them is about its size, which is to say, huge.

Another is that the level of public awareness about the problem is surprisingly high compared with public familiarity about other civic issues, according to an expert who collaborated with the polling firm in putting the survey together.

Finally, substantially more people think electronic health-record systems are riskier than paper-based records.

Alan Westin is a principal with the Privacy Consulting Group, Teaneck, N.J., and a professor emeritus of public law and government at Columbia University. Westin worked with Harris Interactive on the survey instrument used to poll 2,454 adults online between June 9 and June 16. Harris Interactive did not include a "margin of error" estimate with the poll results.

Asked, "To the best of your knowledge, have your medical records or health information, or those of a family member, ever been lost or stolen from an organization that had those records?" about 4% of respondents answered "yes," with about 3% reporting it was their own records that had been lost or stolen.

More here:

http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20080708/REG/626135643/1029/FREE

Again we have survey evidence of the concern people have about their medical records slipping out of their control. We ignore such concerns at our peril!

Second we have:

Large hospitals, IDNs drive use of RFID in healthcare settings

By Bernie Monegain, Editor 07/08/08

The market for or radio frequency identification (RFID) in healthcare is booming, according to a new report from the Spyglass Consulting Group.

The adoption and investment in RFID solutions - primarily to track high-value mobile assets, patients and staff members - represents a 204 percent increase from Spyglass' 2005 RFID study, said Gregg Malkary, Spyglass' managing director.

"It solves a real problem of tracking assets, patients and staff," he said.

"RFID investments are growing exponentially as healthcare organizations develop a better understanding of the technology and how it can be used to solve real problems within their facility," Malkary added. "RFID solutions are being deployed to enhance patient safety, increase operational efficiency and optimize business workflow processes. Larger organizations are more likely to make RFID investments than smaller hospitals because they have larger physical footprint making it more difficult to track things."

The Spyglass study found that 76 percent of larger healthcare organizations have invested in RFID-based solutions.

More here:

http://www.healthcareitnews.com/story.cms?id=9516

It is interesting to see how rapidly this technology is being adopted in the health sector. The article warning about the possibility of interference with some medical devices (cited in the full article) with the use of this technology clearly needs to be confirmed soon to make sure a lot of work is not wasted!

Third we have:

Mergers trimming players in healthcare IT field

By: Jean DerGurahian/ HITS staff writer

Story posted: July 7, 2008 - 5:59 am EDT

Health information technology might be a booming business, but industry players agree: It's one tough market.

Faced with reluctant physicians who don't see the bottom-line value of costly electronic systems in their practices, vendors have embarked on plans to better align their products with providers' needs while trying to educate their customers about IT services. Many of those plans include mergers and acquisitions—a sign the market is maturing, insiders say.

In the first half of 2007, the health IT industry saw several large-scale mergers between vendors, especially in the electronic health-records segment. Most recently, SureScripts and RxHub last week announced they had merged to become the largest electronic drug-prescribing network in the country. Another proposed deal involving Raleigh, N.C.-based Misys Healthcare Systems purchasing a controlling interest in Allscripts Healthcare Solutions, Chicago, passed the waiting period for Justice Department antitrust review, Allscripts announced in early June.

Driving the consolidation are high barriers to entry and the larger, more-established competitors who continue to eat market share, said Mike Davis, executive vice president of the analytics division of the Healthcare Information and Management Systems Society. The market is crowded, and only a few players have stayed on top over the past decade, he said. "We've got some dominant vendors," pointing out companies such as Cerner Corp., Epic Systems Corp. and McKesson Corp.

More here:

http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20080707/REG/411750011/1029/FREE

It is interesting to see the way the system is shaking out in the US.

For Australia we are now in the situation where we have two major providers who are well established in the major hospital sector (Cerner and IBA), Global Health in the small hospital sector also has a significant present and only 2-3 major GP system providers – with one (HCN) still pretty dominant.

It would be good to see some more balance in the GP sector in Australia with more pressure to provide really usable and functionally rich systems. Significant market dominance is never a good thing in my view.

Fourth we have:

CCHIT Certifies 18 More EHRs

The Certification Commission for Healthcare Information Technology in recent weeks has certified specific versions of 18 more ambulatory electronic health records systems under 2007 certification criteria.

Several of these products received pre-market conditional certification, meaning they will be fully certified once use at a physician office is verified.

CCHIT now has certified 50 EHRs under 2007 criteria. The commission no longer is accepting applications for 2007 certification, although there may be products that have not yet completed the process. The commission on July 1 began accepting applications for certification under 2008 criteria.

More here:

http://www.healthdatamanagement.com/news/certification26584-1.html?ET=healthdatamanagement:e495:100325a:&st=email&channel=electronic_health_records

The steady progress the Commission for the Certification of Health IT is making is really impressive. As they move to the 2008 criteria the functional and technical standard required to be certified is becoming reflective of a really first rate system. Given 100% conformance is required there are soon going to be some very good ambulatory care systems available for US clinicians.

Fifth we have:

Australian Medical Association hypocritical on Medicare

Article from: The Daily Telegraph

By Sue Dunlevy

July 11, 2008 12:00am

ONE health minister has been sued for defamation by an AMA president, another had to spend $300 million to avert a hospital strike when the doctors' insurance fund went bust and now new Health Minister Nicola Roxon is at war with the doctors' union.

This time it is the Health Minister apparently on the front foot, freezing the AMA president Rosanna Capolingua out of Kevin Rudd's 2020 Summit, refusing her a place on new health committees and threatening to let nurses take over many of the doctors' traditional roles.

But Roxon is about to learn, as her predecessors did, that this old-style doctors' union has a very powerful influence over this nation's health system.

And there is no greater proof of this than the way the AMA has for nearly a decade thwarted repeated government attempts to eliminate the need for you to visit a Medicare office to get your Medicare rebate.

Nine years after former Health Minister Michael Wooldridge first promised patients they could get their Medicare rebate paid direct to their bank account from their doctor's office, only 10 per cent of Medicare rebates are being paid this way.

More than $700 million of taxpayers' money has been spent on equipment and systems to streamline the payment of Medicare rebates direct from a doctor's office, but doctors won't adopt the system.

The government is even offering doctors a bonus worth up to $1000 to use the system.

They also pay them 18c every time they process a Medicare rebate in their office.

But instead of a reduction in the number of people visiting a Medicare office, there has been an increase - up from 80,000 to 85,000 a day.

More here:

http://www.news.com.au/dailytelegraph/story/0,22049,23999743-5001031,00.html

From Australia’s second most conservative tabloid this is quite a blast at the AMA. It also reminds us – if any reminding was needed – that without strong support from the medical profession even the simplest e-Health initiative is likely to flounder badly!

Sixth we have:

Input sought on e-health

Abstracted from The Australian Financial Review

NEHTA in Australia is seeking public submissions on a privacy blueprint for individual electronic health records (IEHRs). The process is an important part of resolving some of the concerns regarding access to sensitive information that would be stored in IEHRs.

More here:

http://www.businessspectator.com.au/bs.nsf/Article/Input-sought-on-e-health-GBUDZ?OpenDocument

It is important that anyone with an interest do carefully review and comment back to NEHTA on their thoughts on the privacy blueprint. (www.nehta.gov.au).

The report is found here:

http://www.nehta.gov.au/index.php?option=com_docman&task=doc_download&gid=495&Itemid=139

E-Mail comments can be sent to privacyblueprint@nehta.gov.au

Comments are due by August 8, 2008

Last we have our slightly technical note for the week:

A Patch to Fix the Net

A major flaw in the basic design of the Internet is being repaired by a large group of vendors working in concert.

By Erica Naone

On Tuesday, major vendors released patches to address a flaw in the underpinnings of the Internet, in what researchers say is the largest synchronized security update in the history of the Web. Vendors and security researchers are hoping that their coordinated efforts will get the fix out to most of the systems that need it before attackers are able to identify the flaw and begin to exploit it. Attackers could use the flaw to control Internet traffic, potentially directing users to phishing sites or sites loaded with malicious software.

Discovered six months ago by security researcher Dan Kaminsky, director of penetration testing services at IOActive, the flaw is in the domain name system, a core element of the Web that helps systems connected to the Internet locate each other. Kaminsky likens the domain name system to the telephone company's 411 system. When a user types in a Web address--technologyreview.com--the domain name system matches it to the numerical address of the corresponding Web server--69.147.160.210. It's like giving a name to 411 and receiving a phone number, Kaminsky says.

The flaw that Kaminsky found could allow attackers to take control of the system and direct Internet traffic wherever they want it to go. The worst-case scenario, he says, could look pretty bleak. "You'd have the Internet, but it wouldn't be the Internet you expect," Kaminsky says. A user might type in the address for the Bank of America website, for example, and be redirected to a phishing site created by an attacker.

More here:

http://www.technologyreview.com/Infotech/21058/?nlid=1199

This flaw has been widely reported and certainly seems to be been a major issue in internet security that has been well handled co-operatively. It is interesting how such issues can be around for so long. There was also a report this week of a bug in a key part of the Unix on which both MacOS and others are based that has taken 33 years to be tracked down and fixed!

More next week.

David.

Thursday, July 10, 2008

Evidence Based Medicine – An Idea Whose Time Must Soon Come!

The following appeared a little while ago.

The Benefits of Evidence-based Medicine in EHR Systems

June 10, 2008

Evidence-based medicine is often admired but seldom practiced. It is rarely practiced because few physicians have the time to critically appraise the medical literature; an unfortunate reality considering the impact on quality of care, and the fact it could be changed.

When integrated into an electronic health record (EHR) system, evidence driven decision support is presented to the physician at the point of thought, providing crucial evidence-based literature that promotes timely and informed medical decision making. Further integration with a single platform solution that includes an electronic prescribing module provides the physician with objective, medication therapy decision support at the point of prescribing.

Integrated seamlessly into a practice’s EHR, e-prescribing provides additional information, including the cost, efficacy and adverse effects of various medication-based therapeutic alternatives to help the physician make the best prescribing decisions.

Three published estimates suggest that physicians are directing 80% of the spending in our $2 trillion health care market. Yet if you consider the information that we physicians bring to these spending decisions, frankly, it is primitive and pathetic. Imagine physicians as purchasing agents with $2 million annual budgetary authority. Studies show that we physicians don’t know how much the drugs and diagnostic tests that we order cost, and we lack comparative information about their effectiveness and adverse effects. Furthermore, our compensation is largely disconnected from the quality and cost-effectiveness of our performance. Is it any wonder that the U.S. has the most expensive health care in the world, while perennially ranking near the bottom of industrialized countries in metrics like healthy life expectancy?

Health information technologies, especially EHR systems, are often promoted as the solution to much of what ails our health care system. The implementation of technology has become a powerful political issue, but in such a fractured healthcare system, adoption remains a constant struggle for small and medium-sized practices.

Evidence-based medicine (EBM) promises to displace Authority Based Medicine, wherein practicing clinicians simply followed the recommendations of expert thought leaders in the healthcare community. These thought leaders were usually identified by their affiliation with distinguished academic medical centers with successful college football programs.

Much more here:

http://ehrscope.com/blog/the-benefits-of-evidence-based-medicine-in-ehr-systems/

This article makes a series of useful points.

First among them is the level of control that physicians have over health expenditure. Linked to this it would seem that there is a real obligation to use that control wisely. As the article goes on to make clear there are a number of barriers to that happening. Among these is just the scale of the knowledge management task modern medicine poses to practitioners as well the difficulty there can be in accessing reliable, trustworthy evidence on what the appropriate thing to do is in real time with the patient sitting in front of you.

Second, as is laid out later in the article, there is compelling evidence that EBM saves both lives and money.

Third there is now increasing evidence that provision of paid incentives for quality of care can not only change behaviour but also still save substantial sums of money.

What is needed is to have available clinical systems which make the search for evidence and then its application to care seamless and as effortless as possible. Also we need systems – such as those being developed by Pen Computing in Australia – that make quality audit and clinician feedback as seamless as possible.

There is an opportunity to make a huge difference with such systems. We have started down the path but there is much more to do both in system and incentive design as well as information provision and decision support.

David.

Wednesday, July 09, 2008

Software Errors Can Kill – We Need to Recognise the Issue!

The following article appeared a few days ago.

Flaws in medical coding can kill

Spread of computers creates new dangers, FDA officials warn

| Sun reporter

June 30, 2008

WASHINGTON - After a routine piece of medical equipment started mysteriously killing hospital patients a few years ago, the federal government turned to a small team of its software experts in suburban Maryland for help.

The team's discovery - a flaw in a computer code that caused a drug pump to administer heavy overdoses - led to a recall, warnings and rewriting of the equipment's software. The discovery also illustrated a new threat behind some lifesaving medical devices.

Microprocessors run everything from patient monitors to artificial pancreases, and potential software flaws are a growing concern. A product might not malfunction because it was poorly designed or badly made - the traditional suspects - but because the computer code running it includes a mistake. The impact of that glitch can be increasingly serious because the latest automation is removing the doctors and nurses who watched for machine mix-ups.

"The world of technology is allowing us to do things we never thought possible, and it's largely a great advance," said Larry G. Kessler, who directs the Food and Drug Administration Office of Science and Engineering Laboratories, which oversees the team of software sleuths at White Oak in Montgomery County. "Where it gets to be scary is, we used to have more human intervention. With software doing more now, we need to have a lower tolerance for mistakes."

Of 23 recalls last year that the FDA classified as life-threatening, three involved faulty software.

Manufacturers test and inspect the software on their products, such as dialysis systems and patient monitors, before putting devices on the market. But they've been slow to follow the FDA in adopting new forensic technology because it is costly and still evolving, industry officials say. As a result, FDA software specialists are amassing evidence to show companies the value of the new testing. Meanwhile, traditional software checks, while good at detecting some flaws, are not thorough enough to find every mistake, according to computer scientists.

"If architects worked this way, they'd only be able to find flaws by building a building and then watching it fall down," said Paul Anderson, vice president of engineering at GrammaTech, which has sold forensic software technology to the FDA and medical device companies.

Finding a killer buried in a medical device's source code is not straightforward detective work. The directions for an implantable defibrillator might run over 100,000 lines - as long as War and Peace - and cover a multitude of possible actions that could take a decade for the device to run through. Fitzgerald's team of investigators doesn't have that kind of time, especially when patients are dying.

Much more here:

http://www.baltimoresun.com/news/health/bal-te.fda30jun30,0,912831.story

This is a really important article in my view as it reminds us just how potentially dangerous it can be to assume the operational software in both devices and indeed in clinical systems can be – and how hard it can be to discover just what the problem is.

The application of techniques used to check the software that controls space rockets – static analysis – seem like just the right thing to do. It seems to be likely it will not be long before this and other techniques become mandatory for all new devices and systems. That may not be a bad thing!

David.

Tuesday, July 08, 2008

NEHTA Privacy Blueprint for the IEHR – How Much Progress Does it Reveal?

In this article I review the Privacy Aspects of the recently released document.

The document can be found here:

http://www.nehta.gov.au/index.php?option=com_docman&task=cat_view&gid=-1&Itemid=139

There are a few positive points to be made about this document.

First, it does appear to have headings that cover all the major issues.

Second , it has been developed with the input of a range of people – according to Appendices F & G – that I know to understand most of not all of the issues.

Third it is clearly written and nicely comprehensible to non-specialists in the privacy / EHR domain.

So far, so good – so what is wrong?

A few things as I see it.

1. Given the importance of this topic – a document at even this high level has been a very long time coming. The initial material is now close to two years old.

2. Much of the analysis found in this document was available 3 years ago – having been developed by Clayton Utz in January 2005 for the HealthConnect Program. I can’t see this present document advances the state of play much at all. (Sadly these documents have all been pulled down off the web by the re-vamp of the Commonwealth Health Department web site following the Labour victory. If you want a copy for your files let me know. The full 3 documents are about 1.4 Megs as .pdf files)

3. It is not clear why, if there are Draft Privacy Impact Statements that have already been developed, that these are not also made available for discussion and review.

4.NEHTA is seeming very uncertain on the way forward with most of the major issues – while I recognise this is a consultation paper one would have liked clarity as to just what NEHTA is proposing in each area.

5. NEHTA seems on a number of topics to be rather too concerned about cost and/or technical difficulty rather than ensuring public confidence.

Overall I think we are quickly reaching a point where NEHTA needs to say, clearly, what is exactly proposed, what the cost and functionality tradeoffs are why they want to go down specific paths. This is the document that should attract the detailed comment – not this rather short and rather less than decisive effort.

Of course all this assumes one thinks the IEHR concept is a good one. Until vastly more detail – including costs, real benefits, provider engagement strategies, data quality strategies, timelines, technologies, security approaches, private sector interface approaches and strategies and implementation phasing and delivery are provided we and COAG run a real risk of buying a ‘pig in a poke’. We must not let that happen without vastly more information – provided before COAG meets – not after!

David.