Web 2.0 and the Semantic Web – The Healthcare Viewpoint.

The following really interesting article came to my attention a few days ago.

Healthcare and Emerging Rich Web Technologies – The WEB 2.0/Semantic Web Challenge and Opportunity

Over the years, healthcare organizations have had to respond to many different changes – from advances in diagnostic and therapeutic procedures to the emergence of concepts such as managed care and telemedicine. Healthcare is fast becoming one of the most competitive and value added industries worldwide with many technology driven developments in diagnosis, treatment, care provision, patient monitoring and healthcare infrastructure.

One such technology is the Internet. The Internet has transformed various other industries by enabling the widespread sharing of information and allowing the creation of new business relationships. Public information increases on web sites, and consumers use the Internet to find information, communicate with friends and family, plan trips, and shop. It is expected that both the scope of applications and the number of Internet users will continue to grow as technologies improve and new online applications continue to emerge.

In healthcare, the Internet – with its powerful penetration and scalability – has the ability to empower patients, support information exchange, and consequently result in new operational strategies, business and care delivery models. To date, the use of the Internet in healthcare has been limited to e-commerce and e-mail communication between doctors. The Internet's potential, however, is increasingly being harnessed to transform healthcare delivery at the patient level. From growing email use by patients and consumer e-commerce in the drug market, to rising electronic procurement by hospitals, Internet diagnosis and eHealth, the use of the Internet in active healthcare delivery is rapidly gaining ground. Patients create online support communities, search for medical information, and share their experiences, while health care professionals get access to the latest information in their field, consult with their colleagues, and communicate with their patients. Indicative of the impact of Internet in healthcare is the fact that almost every healthcare business – from insurers to hospitals to pharmaceutical companies – has a dedicated Web site.

With the emergence of next generation rich web technologies, such as WEB 2.0 and Semantic web, the creation of a more dynamic and responsive online experience is within reach. This will, in turn, have an effect on how the web is used within the greater healthcare domain, presenting both new challenges and new opportunities.

……

Conclusion
Health-related activities can benefit enormously from the Internet. The large number of stakeholders in healthcare – general practitioners, specialists, nurses, patients, administrators, researchers, and others - can take advantage of the Internet and its capability to support communication, and improve access to health information, thus forging new relationships among those stakeholders. Although a number of technical, organizational, and policy issues need to be addressed, especially in areas such as security, reliability, and timely transmission of information, the Internet has the potential to improve the quality of care, expand access to it, and reduce its cost.

Next generation healthcare information systems will not only allow the exchange of data between heterogeneous systems, but will also enable the representation of complex medical contents. Intelligent search engines, virtual agents and very specific data analysis tools will process semi-structured data and will help make the latest, quality assured information available for health care professionals, executives and patients. Health information generators will search for individual person-centred information in the web, using person-specific information from the EHR and will design health promotion programmes based on the latest evidence-based, quality-assured knowledge.

However, Rich Web Technologies should be seen as a double-edged sword. The main opportunities lie in the fact that consumers will have even better possibilities to find, aggregate and appraise health information than today. On the other hand, one might fear that this may lead to a further over reliance on external information, a process of disintermediation between patients and healthcare professionals and erosion of the patient-physician relationship.

Such concerns will however not stop the development of these technologies, as health information is still some of the most sought after on the web. People will not stop short of using these technologies for health products and services, researching the attributes and reputation of health products and services with a far greater sophistication than on today's web. The World Wide Web as it exists today might be just at the beginning of a health informatics revolution.

The complete long and informative article is found here:

http://www.obbec.com/specialreports/86-healthcare-it/1828-healthcare-and-emerging-rich-web-technologies-the-web-20semantic-web-challenge-and-opportunity/

This is a good perspective on these technologies that recognises the human dimension that must be addressed as well as clearly understanding the complexity of health care and the difficulties associated with the successful use of technology within the sector.

A valuable briefing and update.

David.

The Healthcare Supply Chain – An Important Part of the E-Health Agenda

iHealthBeat published this interesting feature recently

Healthcare Supply Chain Coalition Hits Milestone

by George Lauer, iHealthBeat Features Editor

The word of the decade in health IT is interoperability. It conjures up images of nurses and doctors using compatible digital languages and technological syntax in diverse systems and organizations all over the country.

The image shouldn't stop there. It should include the people who manufacture and order the materials used in health care -- everything from bandages and bedpans to implants and X-ray machines. And it shouldn't stop at the border. Supply chain interoperability is an international effort.

While the quest for interoperability marches on in legislatures, board rooms, hospitals and doctors' offices, a parallel march is taking place in shipping and receiving.

Last week, the organization leading the campaign, the Healthcare Supply Chain Standards Coalition, announced it has reached a milestone. The Standards Coalition, a collaborative of 30 organizations, is combining its efforts with newly formed GS1 Healthcare US.

GS1 Healthcare is descended from the organization that developed the ubiquitous Universal Product Code, or UPC, used in retail, shipping and manufacturing. GS1, based in Brussels and New Jersey, launched its Healthcare US division earlier this year.

…..

Global Perspective

Although the legal requirement deals only with the U.S., the Standards Coalition is taking a global perspective.

"This is all happening in concert," Dudas said. "We have been in direct contact with other countries working on the same problems. For the most part, the global health care industry is moving forward in unison. GS1 is the global standard; that's another reason we're aligning ourselves with GS1 Healthcare," Dudas added.

France, Australia and Turkey are particularly active in the effort to establish international supply chain standards in health care, according to Dudas.

MORE ON THE WEB

• GS1 Healthcare
• Healthcare Supply Chain Standards Coalition
• National Alliance for Health IT

More here:

http://www.ihealthbeat.org/articles/2008/5/29/Healthcare-Supply-Chain-Coalition-Hits-Milestone.aspx?a=1

This is an important reminder that part of the E-Health Agenda has to include those basic areas that can contribute to the effectiveness and efficiency of the health system. Moreover I have at least one colleague who, rightly, believes that better logistics can also improve the quality and safety of the care the patient ultimately receives.

Those of us who are focussed more clinically tend to forget the importance of systems that support logistics, human resources, financial management and rostering (among others) in the overall picture.

NEHTA has been active in the supply chain area, however, sadly, their approach here has mirrored what we have seen elsewhere and progress has been slower than might have been desired. At least the GS1 approach is what NEHTA has adopted!

There is money to be saved with proper adoption of these system that can help support other activities and we should be making these savings sooner rather than later.

David.

Guest Commentary - Dr Sam Heard on “Why is it Taking So Long?”

I have been working in Health Informatics my entire career as a doctor and I plan to see interoperable health records somewhere in the world before I retire (don't worry I have more than 10 years to go). Where to concentrate my time? Australia? It may well take some time to recover from the past 5 years. The UK are trying much harder, but the environment is hostile and legalistic and only those companies with massive purses or undue cunning are surviving (actually these features are necessary but not sufficient). Denmark and Sweden are taking up the archetype approach of the new ISO standard much championed by my close colleague Dipak Kalra, who like me, has been very involved in developing the openEHR specifications. Other countries are, like Australia, betting on HL7 CDA and IHE for access. Actually, we need messages, stand-alone documents and service protocols. And, it is now being realised, standard expression of clinical content. This is something that openEHR is good at but it is not clear that it is necessary until people really start to share information. It is interesting that openEHR, with its development largely in Australia, began to be taken seriously in countries like the UK and the Netherlands who had already embraced HL7 version 3 and CDA.

There are two broad visions of the e-health future which people now embrace.

1. A world where every vendor goes out and builds a system just how they want and makes it do everything that their users want. "Nothing should get in the way of that". Other users and patients can then get access to this information and share it via messages. "Just tell us what you want and we will give it to you". Vendors and clinicians spend years configuring these systems: all unique and each working with a variety of messages that are sent in the local environment.

2. A world where there is a standard format for personal health information and a standard service interface for reading and writing that information. How personal health information is actually stored behind the service is up to the vendor of that EHR service. There will be bells and whistles to go with each flavour. Application vendors will write their applications based on the standard EHR and configuration will be done in a collaborative and cooperative space. Hospitals and even general practices (if they wish) will be able to have their records independent of any clinical application.

Patients will too! Clinicians take a key role in determining what content is required and how it may be structured effectively and efficiently to 'boost' their performance. At times data to be collected will be for the person's long term benefit, such as determination of risk of stroke or other preventable catastrophe. At other times it will be structured to ensure the best possible outcome for the patient, such as an emergency presentation of chest pain.

I have chosen to work on the second approach since 1986. Why am I working on this when the first is the massively dominant approach at the moment? The answer is: because I believe it will get their first. "How?" you might ask. Simply because the first approach cannot deliver. Imagine if we worked in a world with 1000s of word processor applications - actually 100,000s - which did whatever you needed to allow you to write things that were important to you in just the way you wanted. And then each vendor could get together and agree how to use XML or other standards to get the paragraphs about your family, those about your medication, or those with pictures so you could share them with colleagues doing the same sort of work. Each of these messages would be specific to that type of information and ideal for exchanging these. We could even have special messages for sending information about more complex grouping of these - which could be slightly different if required in different jurisdictions. Does it sound plausible? Well, if you consider the complexity of health information compared to word processing documents, then you begin to realise why it is not attractive to me.

So where to start? The first problem is to agree what is needed clinically, how to allow structure and narrative to coexist in a manner that helps clinicians find relevant information. To do this we must be sure that the critical things that computers need to provide the functionality we seek are done in the same manner throughout. The rest, in openEHR, is in the Archetypes: the clinical statements of what is to be recorded and how it may be structured. These statements are formal and can be used, in the first instance, to provide Vendors in our current setting with a very helpful indication of what is required and what will be shared. Ian McNicoll has discovered in his work with clinicians in the UK NHS that they are very good at saying what they don't want but find it much more difficult to say what they do want. The 'maximal dataset' archetypes provide the starting point. The sponsors for specifying content are jurisdictions and the international clinical community.

What is next? Well, hospitals and jurisdictions can now choose to hold their records in a standard format; not just an exchange but at the heart of their system. Their purchasing then requires applications to read and write to their records, just like a locum clinician will be expected to use the clinic record system. But now they can bring in an intensive care application that suits, the ophthalmologists can use their own application with all the features they require and the gastroenterological researcher can even collect their research data in the clinical environment (after all 95% of it is straightforward clinical data). So far this has only happened twice, but this year it looks like a more will take the step. After all, if we are to have any progress in any field we need early adopters. If the collective 'configuration' is available through shared sets of clinical archetypes then vendors can choose to build their product on a standardised EHR. The benefit is that all the transformations required can be cooperatively determined with shared tools and the evolution of the information is not their responsibility. There are now 3 clinical application vendors doing this in Australia and 2 in the Netherlands. These applications then become the choices for the hospitals and others with standardised health records.

It will take a while before the real benefits are obvious. It will, after all, be like having Microsoft Word files - even if you use Open Office or whatever. Australia was on the brink of taking this route - 'common sense' pulled us back. With Denmark and Sweden now joining the UK and pursuing this path and changes at the helm at many levels in Australia, it might be time to look over the precipice again. It feels safer when you jump with others.

Declared interest:

Director of the openEHR Foundation

CEO of Ocean Informatics who make a living supporting the uptake of openEHR.

----- End Commentary.

All I can say is Sam is a very patient man – as I must be - given I started at this in 1984. I see this as a bit of a ‘cri de coeur’ (sic).

Enjoy and please comment.

David.

A Blog Submission to the National Health and Hospitals Reform Commission

I e-mailed this submission today to the NHHRC.

----- Begin Submission

30 May, 2008

National Health and Hospitals Reform Commission

More and Associates Submission

More and Associates is a small consulting firm which consults in the e-Health domain.

More and Associates are convinced there is overwhelming evidence that appropriate deployment and use of information technology in the Health Sector (e-Health) can enable much enhanced sustainability, quality, safety, efficiency and effectiveness in the Health System.

The professional evidence supporting this contention is available at the following URL:

http://healthit.ahrq.gov/portal/server.pt?open=512&objID=650&PageID=0&parentname=ObjMgr&parentid=106&mode=2&dummy=t

The Health IT Bibliography is a unique and highly valuable resource which should be thoroughly considered by the Commission in its deliberations.

Detailed reviewed references cover the following areas of e-Health value, adoption and deployment.

Organizational Strategy

Adoption Strategies

Business Case

Technology

Clinical Decision Support Systems (CDSS)

Computerized Provider Order Entry (CPOE) Systems

Electronic Health Record (EHR) Systems

Electronic Prescribing (eRx)

Health Information Exchange (HIE)

Standards and Interoperability

Evaluation

Evaluation Studies in Health IT

Patient Safety

Workflow Analysis

Additional evidence is also available from my blog on Health IT which has over 450 articles on the topic.

See this URL:

http://aushealthit.blogspot.com/

We believe an appropriate consideration of the place of e-Health in all the reform proposals developed by the Commission is vital. If this is not done a key enabler of reform may be ignored to the peril of the success of the whole reform enterprise.

Yours sincerely,

Signed

David G. More

Executive Director

----- End Submission

I hope they listen.

David.

Useful and Interesting Health IT Links from the Last Week – 01/06/2008

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

These include first:

How important is Mirth?

Posted by Dana Blankenhorn @ 7:44 am

Fred Trotter recently decided to turn his regular talks on open source health computing into a series of blog posts. They are well worth looking at.

His review calls Mirth the most important interoperability project out there. This despite what he acknowledges are weaknesses in the underlying HL7 standard.

Mirth is a great effort. There are implementations for Windows, Linux, the Mac OS, even JBOSS middleware. The most recent version is 1.7.1, released on April 30, and dozens of bug reports and improvement suggestions have already been posted.

More here:

http://healthcare.zdnet.com/?p=994

The answer to the question I believe is very important. This software is a key enabler of interoperation between different systems and to have it open source and available freely is really a good thing.

The web site for the project is well worth a careful review.

Second we have:

GPs reject web-based ‘Healthbook’ record

Andrew Bracey - Friday, 30 May 2008

GPs have roundly dismissed proposals for a Facebook-like system of personal electronic health records, pointing to issues of reliability and patient privacy as major stumbling blocks.

A recent national survey of 151 GPs by Cegedim Strategic Data for Medical Observer revealed just 13% of GPs were convinced the concept would work.

The proposal – dubbed Health­book – emerged from the recent 2020 Summit and involves the establishment of individual health profiles controlled by each patient.

The Internet-based system would allow patients to store medical data and share it with health professionals.

GPs were cynical about the proposal. Just over 28% said they did not believe such a system would ever be realised.

Patient privacy, security and incomplete record-keeping were cited as key barriers to safe implementation.

More here (if access available):

http://www.medicalobserver.com.au/medical-observer/News/Article.aspx/GPs-reject-web-based-%E2%80%98Healthbook%E2%80%99-record

I find this level of negativity quite interesting – I wonder how well the proposal was explained to the respondents before their views were sought.

Third we have:

Vic IT projects in crisis: Auditor

Fran Foo | May 28, 2008

PEOPLE with tunnel vision are running some of Victoria's most complex ICT projects, and the ramifications are hurting the state's bottom line.

Victoria's Auditor-General Des Pearson today said such projects, often involving myriad government agencies, were increasingly late and over budget.

Mr Pearson made the comments as he released an audit report on Project Rosetta, saying the whole-of-government enterprise directory project was a prime example of the deepening malaise.

"The time and cost overruns experienced in Rosetta are becoming commonplace when reviewing multi-agency ICT implementations ," he said in a statement.

"While not at the same scale as those experienced in other projects recently audited, such as HealthSMART, these recurring features indicate that lessons need to be learned."

In April, Mr Pearson said the $320 million HealthSMART project is two years overdue.

Meanwhile, Rosetta incurred additional costs of more than $10 million, and was delivered seven months past its deadline. The directory was nearly four years in the making, with work commencing in August 2002.

More here:

http://www.australianit.news.com.au/story/0,24897,23773298-15306,00.html

It seems that major projects in the public sector are virtually always very problematic. This lesson should not be lost on those in NEHTA proposing a Shared EHR (or whatever it is called today). A decentralised locally driven process would seem to me to be much more sensible.

Fourthly we have:

Data breach reporting a scramble

Karen Dearne | May 27, 2008

BANKS say they are well placed to adopt new data breach notification rules, but other businesses may struggle to get protections and policies in place.

The Rudd Government is considering making reporting of data breaches mandatory as part of a review of the Privacy Act.

In the meantime, federal privacy commissioner Karen Curtis is seeking public comment on an interim voluntary scheme.

ANZ Bank privacy compliance manager David Templeton said it had had an incident reporting system in place for a number of years. "Any privacy incidents are recorded in a database, which reports issues in real time to a central compliance area for review," he said.

"We then consult with the relevant business area to decide what action is appropriate."

Symantec Pacific vice-president Craig Scroggie anticipates a windfall for security vendors arising from new legislation. His firm recently acquired Vontu, a leader in data loss prevention tools.

"Data loss is clearly a big issue because of the federal privacy commissioner's draft guidelines for voluntary notification, and the forthcoming Australian Law Reform Commission recommendations on a mandatary scheme," he said.

"Data loss is not just an IT issue, it's a significant business issue, as information is a prime company asset. Data loss and leakage are hot topics right now, but they're not new."

More here:

http://www.australianit.news.com.au/story/0,24897,23762990-5013040,00.html

What I am not clear on as yet is just what the implications of this are for the health sector. It would seem to me that everyone who holds computerised (or even paper based) health information needs to keep an eye as to what is going on here.

Fifth we have:

One-stop shop for Centrelink, Medicare

Patricia Karvelas, Political correspondent | May 28, 2008

SOME Centrelink and Medicare outlets will be combined into "one-stop government shops" under a Labor plan to improve access for customers.

The overhaul of Centrelink, to be unveiled today, will also involve the introduction of digital forms to reduce processing times and allow for quicker decisions.

While a national rollout of the one-stop shop concept remains a long-term plan, Human Services Minister Joe Ludwig said that in areas where the viability of the local Centrelink office might be in question, the all-in-one option would enable towns to keep their branch open. Uniting offices would be trialled in one-off locations under a $10million plan.

Senator Ludwig said some of the service improvements, to be announced today, were aimed at introducing new technology to Centrelink agencies, including digital scanning of documents.

Online "smart forms" would allow questions about customers' circumstances to be asked in one hit for a range of benefits.

"Similarly, better use of available technology could mean that, for students, requests for information from Centrelink can be sent via SMS," Senator Ludwig said.

More here:

http://www.theaustralian.news.com.au/story/0,25197,23769877-23289,00.html

While at first blush this may seem like a good idea I wonder just how people would feel talking to the same customer service officer about both their Centrelink payments and their health claims. The possibility for all sorts of privacy breeches and possibly some forms of abuse of privilege seem higher in this environment. The officers would potentially have access to a huge amount of private information on a client to be able to manage all these programs from a single visit – and that may not be uniformly a good thing.

This article may also be relevant.

Medicare IT outsourcing deal delayed

Karen Dearne | May 29, 2008

THE planned retendering of Medicare's key ICT outsourcing services contract has once again been postponed while the Human Services Department awaits direction from the Gershon Review of federal government agencies' use and management of IT systems.

Human Services Minister Joe Ludwig says the plan to take a "more universal" approach to ICT requirements will affect the timing of approaches to the market by agencies.

"We have a number of major contracts - including the Medicare Australia ICT services contract - which are due to expire over the next 12 to 24 months," Senator Ludwig said in a statement.

"A key element of the department's service delivery reform strategy involves strategic portfolio approach. Our agencies, including Centrelink, Medicare and Child Support, are collectively among the biggest users of ICT within Australia."

More here:
http://www.australianit.news.com.au/story/0,24897,23777892-15306,00.html

Sixth we have:

Rollout of NHS e-record software faces more delays

22 May 2008 09:15

Connecting for Health and CSC may be preparing a new contract extending the schedule for implementation of the Lorenzo software until 2016

Further delays have beset the implementation of a key feature of the NHS National Programme for IT.

According to a paper released online by the North West Strategic Health Authority, NHS Connecting for Health and local service provider CSC are preparing a new schedule, extending to 2016, for installation of the Lorenzo software within health service trusts. Lorenzo will provide the core clinical information system for hospitals in the north and east of England and the Midlands.

This is at odds with a National Audit Office report released on 16 May, which said the implementation of electronic care records, the core of the national programme, had been delayed to 2014-15, making it four years late.

Continue reading here:

http://news.zdnet.co.uk/itmanagement/0,1000000308,39422253,00.htm

This is a little worrying. One really hopes some of this ground can be made up over the next few years.

Last we have:

Call for e-health to ‘permeate’ rural Scotland

27 May 2008

E-health should permeate thinking about every aspect of remote and rural healthcare, according to a newly-published report on healthcare in remote areas of Scotland.

Scotland’s Remote and Rural Steering Group, 'Delivering for Remote and Rural Healthcare: what it means for you', sets out a framework to develop a sustainable care system in remote Scotland. Its findings have been accepted by the Scottish government.

The report calls for Scotland’s eHealth Strategy Board to ensure that the level and quality of connectivity is the same across Scotland and says that remote and rural communities should be supported by a “first class IT infrastructure”.

The steering group said that the principles underpinning a technological approach should be that specialist advice could be provided from a distance using videoconference, telephone or e-mail, that videoconferencing could avoid the need for traveling to a central point and that digital data such as blood tests and ECGs could be transferred from remote sites to other points, enhancing diagnosis.

More here:

http://www.ehiprimarycare.com/news/3784/call_for_e-health_to_%E2%80%98permeate%E2%80%99_rural_scotland

It seems that some of the ideas for remote Scotland might be worthwhile considering for remote Australia given our plans to improve the network connectivity all over Australia with the new Broadband investments.

More next week.

David.

Rapid Leaning to Improve Drug Safety in the USA.

The US Food and Drug Administration has announced a very important data mining initiaitive.

F.D.A. to Expand Scrutiny of Risks From Drugs After They’re Approved for Sale

By GARDINER HARRIS

WASHINGTON — Chastened by repeated instances in which popular medicines proved deadly, federal health officials announced a major effort on Thursday to use information on Medicare claims to assess the risks of drugs already on the market.

The new system, called the Sentinel Initiative, will allow officials from the Food and Drug Administration for the first time to monitor almost immediately how drugs affect health. As it stands now, months or even years must pass before officials learn of unexpected side effects that can cost dozens or even thousands of lives.

“It will be a quantum leap forward in F.D.A.’s capacity to monitor the use of medical products that are currently on the market,” said Health and Human Services Secretary Michael O. Leavitt.

In two news conferences, officials made repeated assurances that the agency and other researchers would not have access to any of the personal information of Medicare beneficiaries.

Researchers praised the government initiative, but many said its fruits would take years to realize. And several said the Bush administration’s policy of delivering the Medicare drug benefit through myriad private plans made the effort that much more difficult.

“This is going to take a lot of work,” said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington.

Mr. Leavitt said “the power of this is in the capacity to take disparate databases and use it in a productive way.” Dr. Janet Woodcock, director of the F.D.A.’s drug center, agreed that much work remains to be done.

The Sentinel Initiative has been in the works for years. In 2005, Mr. Leavitt asked the F.D.A. to explore the creation of such a system. In 2006, the Institute of Medicine recommended one, and last fall Congress voted to require the agency to create such a system.

The agency now relies on an unsystematic system in which doctors, patients and manufacturers report problems with drugs and medical devices when they deem them important. One doctor might see an infection following the use of a drug as important to report while another might not. The agency estimates that it receives reports for only a fraction of actual drug effects.

More here:

http://www.nytimes.com/2008/05/23/washington/23fda.html?_r=1&ref=health&oref=slogin

Another report regarding the same initiative is here:

Program Aims for Drug, Device Safety

By Rob Stein

Washington Post Staff Writer

Friday, May 23, 2008; A02

Federal health officials yesterday announced plans to begin mining the medical records of millions of patients to try to identify safety problems from drugs and medical devices more quickly.

The Sentinel Initiative will enable the Food and Drug Administration and others to analyze the growing number of databases of health records compiled by the government, health insurers and HMOs to try to identify drug- and device-related problems sooner than does the current system, which relies primarily on voluntary reporting by individual doctors.

"It will be a quantum leap forward in the FDA's capacity to monitor the use of medical products that are currently on the market," said Health and Human Services Secretary Mike Leavitt. "We are moving from reactive dependence on voluntary reporting of product-safety concerns to proactive surveillance of medical products that are currently on the market. The result will be much improved safety."

The agency plans to start by analyzing data collected about the more than 25 million people enrolled in the new Medicare prescription drug program. State agencies and academic researchers will also have access to the data under a new federal regulation that will go into effect in 30 days, officials said.

"The FDA will eventually be able to query databases of tens of millions of patients almost simultaneously," Leavitt said.

The officials stressed that the system will protect patient privacy by keeping all identifying information confidential.

"FDA will not receive information that identifies individual patients, so patient privacy will remain protected," Leavitt said.

More here:

http://www.washingtonpost.com/wp-dyn/content/article/2008/05/22/AR2008052203918.html

This is a great initiative as not only will it help identify issues with new medicines in the post marketing phase for citizens in the USA but it will also provide valuable information as to what potential problems our TGA should be alert to. That is of course until they get a similar system operational in Australia.

I am sure they have it planned and are just awaiting funding! (I hope).

David.

NEHTA Moves to Exclude the Health Informatics Community from E- Health Summit!

Renai LeMay of the Australian Financial Review sent me this URL an hour or so ago.

http://www.misaustralia.com/viewer.aspx?EDP://1211958074603&magsection=news-headlines-home&portal=_misnews&section=news&title=NEHTA+nuts+out+national+health+records

What it shows is that neither the Health Information Society of Australia (HISA) or the Australian College of Health Informatics have been invited to the summit on the NEHTA Shared EHR (or whatever its new name is). Of course the GPCG and the MSIA are also left out.

This is just nonsense and it now becomes clear the influence of the ‘Dear Leader’ continues unabated in terms of consultation and communication.

It is offensive and a joke that this so called summit should be conducted with no one focussed on e-Health and no one who could really understand, in depth, NEHTA’s proposals.

If this oversight is not fixed in the next few days – you can be sure NEHTA will have lost the confidence of all those who could make its projects work.

David.

Late note: I have also now been told by e-mail other obvious exclusions seem to also include:

- Standards Australia

- HL7

- Consumer Health Forum

- Choice

- The peak privacy lobbies - only Privacy Commissioner invited

All these groups have a major interest in the area.

D.

The Legal Complexity of Electronic Health Records – Does NEHTA have the Answers for Australia?

This very important two part series appeared last week.

Legal electronic records pose complex questions

By: Joseph Conn / HITS staff writer

Story posted: May 19, 2008 - 5:59 am EDT

Part one of a two-part series

Issues surrounding the law and medical records always have converged, but the advent of powerful electronic health-record systems in healthcare have added whole new levels of complexity to that relationship.

“I don’t want to sound alarmist, but this is an extraordinarily significant change in the litigation landscape,” says Kevin Yankowsky, a partner in the Houston office of law firm Fulbright & Jaworski, where he handles healthcare litigation representing both plaintiffs and defendants.

Some key problem areas:

• EHRs are infinitely more complex than paper records. They document not only what was done but also, to a far greater degree, what could have been done but wasn’t. One example is a drug alert fired off by a computerized physician order-entry system that was either complied with or overridden.
• EHR systems can store data about the systems themselves. This so-called metadata includes information on when an electronic record was entered and viewed, by whom, for how long and how often, potentially creating a detailed audit trail that can be used both for legal defense and offense.
• Vendors of EHR systems have not fully adapted their products to this new legal framework, while users of the systems, most specifically healthcare providers, are also playing catch-up in adopting health-record management policies to match the new systems healthcare organizations are installing or have installed.
• Finally, the legal landscape, as Yankowsky and others note, is shifting rapidly, with the tectonics driven in large part by changes in legal guidelines about electronically stored information that are followed by the federal court system but will likely influence similar rules for legal discovery and records production at the state level as well.

“At a very minimum,” Yankowsky says, “it is imperative that healthcare providers start looking at it and making decisions on what they want to do.”

To try and address these problems and give the healthcare industry a battle plan to address them, members of a work group of the Health Level 7 standards development organization met in Phoenix earlier this month. Their aim was to tweak a format that, if followed by adopters of EHR systems, would help their legal health records stand up better in court.

More here:

http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20080519/REG/629638642/1029/FREE

Part 2 followed:

Navigating the legality of EHRs vs. paper records

By: Joseph Conn / HITS staff writer

Story posted: May 20, 2008 - 5:59 am EDT

Part two of a series (access part one here)

The newly proposed HL7 profile "identifies the key infrastructure functions that support management of electronic health records for business and evidentiary purposes," Michelle Dougherty, director of practice leadership for the Chicago-based American Health Information Management Association and a co-facilitator for the legal e-health-record work group, says.

For example, the HL7 guidelines note that legal-record functionality criteria overlap with privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996 as well as state laws. According to the HL7 criteria, a legal EHR system must ensure that the identity of users has been verified and access to the system is under a set of specified controls, that information coming into the system via data exchange is coming from a trusted source and that any change made by a clinician has a recorded attestation.

"If your authentication is weak, then someone on the stand (in court) can say, 'That wasn't me,' " Dougherty says. Another problem area with legal e-health records is EHR system vendors, which have not given the concept of a legal record much priority, according to several sources contacted for this story.

Dougherty says, with an attempt at diplomacy, that some IT vendors have not yet fully come to grips with the needs for outputs that can be used in a legal setting.

"It wasn't a major focus for vendors because they were focused on clinical care," she says. "From AHIMA's opinion, as we looked at (vendors') systems, it was a little bit all over the map. There were some core functions in place. Some were stronger than others. 'There was a lot of variability' would be a good way to say it. And purchasers weren't making it a priority."

But, Dougherty says, as more and more healthcare systems have adopted EHRs, "some of those early adopters raised flags saying we have problems. We can't get this (record) out to take to court."

Auditing changes to a computerized record is a key concern.

"You want to have a policy of how you amend a record," she says. In the paper world, "there were these business rules. You don't want a record thrown out on a technicality because it had Wite-Out on it"; so you use permanent ink. Similarly, with an EHR, "You don't want it thrown out because a system allows a record to be overwritten."

One key to defending an electronic record is the metadata, the stuff of audit trails, loosely defined as "data about data," Dougherty says. Laying down guidelines for the acquisition, storage and reporting of metadata is one of the issues the work group had to address.

"It's information that tells you who created a record and when it was modified," she says. "That's what you're reading in case law in the courts, that metadata creates some security and validity. When you don't have that metadata, the courts make some assumptions you don't want them to make. You can't defend yourself.

"If you look at it from a pure record standpoint, that audit report becomes a key component to assure validity," Dougherty says.

Very much more here:

http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20080520/REG/369052596/1029/FREE

I think it would be fair to say that this issue has slipped relatively under the radar. An exception to that generality is the work the openEHR Foundation (previously the Good Electronic Health Record) did, and continue to do, to address the evidentiary requirements of EHRs. All of the issues raised in these two excellent articles have been certainly discussed and addressed in the openEHR work – although the importance of a range of metadata may not have been emphasised in the way it is in the present articles.

A key point to note is that the problem becomes even more difficult and complex when one starts to consider sharing EHR records and even more problematically when one considered sharing of partial or summary records. Issues around which record has precedence and so on then arise.

Careful reading of both articles is commended to all interested readers. It would be interesting to understand just how NEHTA has addressed these issues I must say! We don’t seem to know as their work has never been made public other than in very high level presentations. That needs to change, and soon, in my view.

David.