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.

Flash from NEHTA RSS Feed!

This just arrived!

Peak Body Summit: 18 June, 2008

NEHTA is hosting a summit with Peak Bodies in the healthcare sector to discuss the introduction of Individual Electronic Health Record for all Australians. The event will be held at Rydges Lakeside in Canberra.

Location: Rydges Lakeside in Canberra

Contact: Kylie.willows@nehta.gov.au

----- End RSS.
There are no more details on the NEHTA Web Site that I can see.

This is all of 3 weeks away!

Where are the discussion papers so stakeholders can contribute via their peak bodies I wonder. A listing of which peak bodies are attending and who they represent might also be a good idea!

It really is time those who are interested in all this start to demand a great deal better.

This is simply not good enough!

David.

Another Conference We Mostly Missed! – Archbishop Tutu Keynotes E-Health!

It seems the Commonwealth had a Ministerial level conference on e-Health a few days ago!

Here are a few reports.

Maginley embraces e-Health opportunities

Thursday May 22 2008

Health Minister John Maginley had the opportunity to chair the Commonwealth Health Ministers Meeting in Geneva, Switzerland, held under the theme “E-Health: Challenges and Opportunities.”

Maginley, according to a press release, was instrumental in setting the agenda of the meeting by working assiduously with the Commonwealth Secretariat over the last year. In his opening remarks, he noted the definition of E-Health for the meeting as a term for all healthcare practices which are supported by electronic processes and communication.

The newly appointed Secretary-General of the Commonwealth Secretariat, Kamalesh Sharma and Dr. Margaret Chan, director-general of the World Health Organization addressed the over forty Ministers of the Health from Commonwealth countries present at the meeting along with their delegations.

With the theme of the meeting being e-Health, seven countries from both developed and developing nations illustrated varying e-Health initiatives in their countries including challenges and opportunities.

The Right Reverend Archbishop Desmond Tutu delivered the keynote address highlighting the significance of the meeting and the decision to address E-Health as an issue. In introducing Archbishop Tutu, Minister Maginley noted the tremendous achievements and the major contributions of the Anglican church leader.

Archbishop Tutu emphasized the benefits of E-health which include distance learning via the internet to increase the health workforce and using e-Health to decrease inequities in health and ensure access to adequate health care services to disadvantaged populations such as the poor and those living in rural communities.

More here:

http://www.antiguasun.com/paper/?as=view&sun=325035096205212008&an=414345099405212008&ac=Local

and

E-health is C'wealth's new agenda

7 May 2008, 0115 hrs IST,RASHMEE ROSHAN LALL,TNN

LONDON: The 53-nation Commonwealth launches world's first international e-health initiative across countries and continents on Sunday in an attempt to harness its members' evidentially extraordinary appetite for hi-tech with health-friendly governance.

Ernest Massiah, head of health at the London-headquartered Commonwealth secretariat, which organises an annual health ministers' meeting in Geneva, said the e-health focus could be a revolution in the making, potentially offering fast-track development opportunities to poor people spread across the Commonwealth.

India, he said, could provide crucial hands-on knowledge because "health workers in some parts (of India) are even now, sending text messages to the central authorities with key epidemiological data".

The Commonwealth's new ‘big idea' is all about how to translate "the amazing diffusion of new technology, such as the mobile phone" into the field of health, where most member-countries significantly lag behind the developed western world.

E-health is a leap of faith for the Commonwealth, which has normally focused its annual health meetings on safer subjects such as last year's non-communicable diseases.

More here:

http://timesofindia.indiatimes.com/World/E-health_is_Cwealths_new_agenda/articleshow/3047564.cms

And

Liow To Attend World Health Assembly In Geneva, Switzerland From Tomorrow

KUALA LUMPUR, MAY 17 (BERNAMA) -- Health Minister Datuk Liow Tiong Lai will be attending the 61st World Health Assembly, the supreme decision-making body for the World Health Organisation to be held in Geneva, Switzerland from Sunday till May 22.

Liow will be delivering a speech at the annual gathering which will discuss issues relating to health including pendemic influenza preparedness, poliomyelitis, climate change and human health, and counterfeit medical products.

…..

It will focus on a range of e-health applications, the ethical, legal and infrastructural challenges faced when introducing e-health.

More here:

http://www.bernama.com.my/bernama/v3/news.php?id=333591

and lastly:

Hon. Minister invites Commonwealth countries to a meeting in Climate Change and Health in Sri Lanka

Monday, 19 May 2008

Sri Lankan delegation headed by Hon. Nimal Siripala de Silva, Minister of Healthcare and Nutrition attended Commonwealth Health Ministers’ meeting held in Geneva on 18^th may 2008. The Hon Minister of Health of the Western Province, Mr. Prasanna Ranatunga, Dr. Palitha Abeykoon and Dr. Nihal Jayathileka, Additional Secretary, Ministry of Healthcare, were the other members of the delegation.

This meeting had been organized by the Secretary General of the Commonwealth, Mr. Kamlesh Sharma and Health Ministers representing nearly fifty Commonwealth countries attended this annual forum. The main theme of discussion in this meeting was the place of E-health in health systems development and health care delivery.Hon. Minister, Nimal Siripala de Silva highlighted the initiatives taken by the Government of Sri Lanka on E health, to improve the quality and equity of health care. Sri Lankan Government has embarked upon an innovative pilot programme in tele-radiology and tele-pathology to seek a solution to the brain drain of their qualified specialized doctors in certain fields, such as radiology and pathology.

He stressed the need for providing continuing education for doctors, nurses and other health personals through E-Health programmes. He further stressed that the development of health information systems and management information systems in hospitals are vital to sustainable development of health systems. In developing countries expanding E Health service has been affected due lack of bandwidth infrastructure around the country, especially in the rural areas where it could be most useful. In Sri Lanka, the government is currently addressing the limitation through the development of the Telecommunication Infrastructure which will be accessible to the health sector.

More here:

http://www.lankamission.org/content/view/266/1/

A report of the conference is to be found here:

http://www.thecommonwealth.org/news/179335/190508chmm.htm

A copy of Archbishop Tutu’s remarks is here:

http://www.thecommonwealth.org/news/34580/34581/179302/160508tutuoped.htm

Presentations given at the meeting are here:

http://www.thecommonwealth.org/doclist/177370/179342/presentations/

The outcome of the meeting is found here:

http://www.thecommonwealth.org/document/179485/2008_commonwealth_health_ministers_meeting__chmm.htm

The key action suggested is as follows

“Ministers requested the Commonwealth Secretariat, bearing in mind its ongoing mandates and importance of coherence with other international efforts, to pursue:

High-level policy dialogues involving the health and information technology sectors, the private sector, health professionals and civil society on the opportunities and challenges of e-health and requested the Secretariat to facilitate this.

• Explore setting up e-health pilot projects in all regions of the Commonwealth.
• Public-private partnerships in e-health.
• Sharing of expertise and technical assistance between Commonwealth countries, both North-South and South-South.
• Leveraging additional resources to support the further development of its work on e-health and development.
• Ministers agreed on ‘Health and Climate Change’ as the theme for CHMM 2009.

Commonwealth Secretariat

Geneva

18 May 2008”

Australia seems to have be missing in action at the meeting – sorry about that! It did provide a written report on e-Health in Australia trumpeting the success of the Eastern Goldfields Project and NEHTA!

The report is here:

http://www.thecommonwealth.org/files/178273/FileName/HMM_G__08_6-EHealthSurvey2.pdf

Read while feeling very strong of stomach! The positivity of the spin is a wonder to behold!

David.

NEHTA Seeks Our Patience but Does Not Explain What it is Doing!

Late last week a couple of reports of CeBIT’s e-Government Forum appeared.

First we had

NEHTA asks for patience on patient records

By Brett Winterford, ZDNet.com.au

May 21, 2008

The National E-Health Transition Authority (NEHTA), the organisation charged with steering Australia's efforts to unify patient records across the nation's healthcare providers, has asked for patience in the face of growing criticism of its progress.

Gil Carter, general manager of authentication at NEHTA, told attendees at the CeBIT's e-government Forum today that critics should consider the "wicked problems trying to be solved" when reading any adverse press about its efforts.

It is widely recognised that healthcare provision in Australia desperately needs a system that connects the disparate silos of paper- and electronic-based health record systems isolated within healthcare institutions in Australia. A unified electronic patient record, one which can be transferred between healthcare institutions, is the "glow on the horizon" for e-health, Carter said.

Carter said NEHTA, funded by both Federal and State governments, has contrary to media reports made some considerable progress on most of the key areas required to build such a connected health system.

Development of unique identifiers for healthcare patients has been allocated to Medicare as of December 2007, he said. NEHTA has also built a comprehensive framework for the development of "premium grade" digital certificates to ensure that records can be transferred securely, and negotiated for healthcare system developers to gain free access to the SNOMED CT standard for clinical terminology to ensure all institutions are "speaking the same language".

"We've done the strategy, the documentation, the standards and procedures," Carter said. "The focus of the next 12 months will be consultation and implementation."

Any lack of progress, Carter told ZDNet.com.au, was a reflection of "the complexity of healthcare".

Read more here:

http://www.zdnet.com.au/news/software/soa/NEHTA-asks-for-patience-on-patient-records/0,130061733,339289144,00.htm

Reporting on the same event we have the following from Computerworld

Govt gets serious about e-health implementation

NETA green lights e-health revolution

Darren Pauli 21/05/2008 16:47:28

The National E-Health Transaction Authority (NETA) will this year action its spate of electronic health projects, set to revolutionise the operations of Australian hospitals and clinics.

The authority is tasked with creating standards for healthcare across areas including electronic document management, pathology and patient identification and privacy. It is an independent government body which interacts with nine separate agencies, and state and federal government.

Speaking at the e-government CeBIT conference in Sydney today, NETA general manager Gill Carter said the agency has entered a phase of "serious implementation".

"Our work in personal e-health records is a five to 10 year transition from paper to electronic [media],"Carter said.

"The biggest benefit of e-health and [affiliate] projects is that people will have access and control over their own health information.

"We need to establish common standards, uphold privacy and work out what consumer access to health information should look like."

Common communication standards are top of the list for NETA, according to Carter, because they allow successful local projects to be deployed nationally.

Read more here:

http://www.computerworld.com.au/index.php?id=255536153&eid=-255

Looks from all this that the old NEHTA is alive and well!

What we have here is a classic case of blaming the customer (i.e. the health system) for being complex and slowing NEHTA down! – Diddums!

The speaker then goes on to say “We've done the strategy, the documentation, the standards and procedures” Well good!

And he then goes on to say "The focus of the next 12 months will be consultation and implementation."

The first step in consultation is to inform stakeholders where things are up to and what is planned. How about now sharing all this with the health sector and other interested stakeholders? It seems to me to be planning to move to any actual implementation without very considerable external review is fool-hardy in the extreme.

Review of recent presentations from NEHTA we discover a few more details about, as an example, the National Authentication Service for Health (NASH).

Gil Carter Presentation 15^th May, 2008 Brisbane (Slide 7)

National Authentication Service for Health

Highlights

• Smartcards for healthcare professionals
• Digital certificates for devices
• Enable trusted authentication, digital signing, encryption
• Learns from previous experiences of PKI in health
• Specify and build during 2008
• Initial operations in 2009

So it seems we are to have Smartcards for every health provider (There are a few hundred thousand of those at last count) and digital certificates for all sorts of devices!

More the whole thing is going to be specified and built in seven months and be ready to operate in 2009!

Well I suppose it might happen – but I doubt it. The effort of reliably identifying every health provider, issuing a smartcard etc is going to be both expensive and time consuming. (The UK NHS took a few years as I recall to do something similar in the NHS). Worse still where is the business case justifying it is the right way to go and the pilot that shows it is practical and workable?

Reliable Provider Identification is both very important and non-trivial. The sooner the detailed plans are available for public scrutiny and comment the better in my view. “Bull at a gate”, unconsultative approaches make very little sense.

At the same session we discover Clayton Utz have undertaken a Privacy Impact Assessment (PIA) of the Individual Health Identifier. This work was begun in August 2007. Again – so where is this report? Especially since the outcome of the review “Identified privacy issues and risks, and made recommendations for mitigating them”. The industry, the sector and the public all have a right to know what is going on.

What is worse is that a “Further PIA planned for final design of UHI Services (mid 2008)” and that no one other than NEHTA (and maybe the jurisdictions) know what the initial PIA said and whether the remediation plans were reasonable. The impact of what is going on here are way broader than that!

Someone really needs to get control of this steam train and make it accountable to its customers – the whole health sector and the public.

David.

Useful and Interesting Health IT Links from the Last Week – 25/05/2008

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

These include first:

Privacy review ready for Faulkner

Karen Dearne | May 21, 2008

A LANDMARK review of privacy laws is set to recommend civil penalties for failure to notify the federal Privacy Commissioner of any data security breaches, Australian Law Reform Commission president David Weisbrot says.

The ALRC's final report on the review of the Privacy Act is due to be presented to the federal Government this Friday.

"Individuals want to know when their personal information has been compromised," Professor Weisbrot told the AusCERT 2008 conference yesterday. “People are aware that electronic databases can be breached, and they fear an increased risk of identity theft."

Professor Weisbrot said many US states had civil penalties for failure to advise affected individuals; in Alabama the penalty is $US10,000 for each breach, while in Florida there is a $500,000 cap on fines.

However, the ALRC will propose that data notifications only be triggered where the breach involves a real risk of serious harm to an individual.

Special Minister of State John Faulkner has committed to an overhaul of the nation's privacy laws in response to the vast technological changes since the Act was promulgated 30 years ago.

More here:

http://www.australianit.news.com.au/story/0,24897,23734229-15306,00.html

It will be important for all of those with an interest in e-Health to keep a close eye on what comes out of this given the sensitivity of health information in the mind of the public.

Second we have:

Evado clinical software for US

Jennifer Foreshew | May 20, 2008

MELBOURNE company Evado is planning to expand its operations into the US following the launch of its low-cost software for clinical trials.

The company, a division of Invision, will today unveil the mobile version of its software, launched late last year.

Evado will run on Intel's Mobile Clinical Assistant and is being used by Dr John Woodard, chief scientific officer at Ventracor, who is the co-inventor of the VentrAssist "artificial heart".

Dr Woodard and his team will use the software on Intel's MCA for a new study to develop a fully implantable device.

Evado founder and chief executive Jennie Anderson said another three organisations were negotiating to purchase the software. The company has a reseller agreement with SeerPharma, an Australian company, with offices in Asia, and another reseller agreement is being negotiated for the US and Britain.

More here:

http://www.australianit.news.com.au/story/0,24897,23725857-15317,00.html

This is really good news that there is some successful innovation happening in this software area in Australia. Good luck to them with the international expansion.

Third we have:

$170m ripped out of GP programs: AMA

May 19, 2008 - 4:20PM

The federal government has ripped $170 million out of existing GP programs to fund its Super Clinics, a doctors' group says.

Australian Medical Association (AMA) president Rosanna Capolingua said the funding had been cut from programs available to all general practices, whereas the 31 GP Super Clinics, costing $275.2 million over five years, were specific.

"The AMA maintains that this money will need to be well targeted at areas of need and must add to, rather than replace, local health infrastructure if it is to be effective," she said.

"These cuts to general practice seem contrary to the government's stated focus on strengthening primary care."

More than $83 million has been cut from GP immunisation incentives plus $110 million from support for e-health and $26 million from after-hours services.

Funding was allocated for an extra 150 scholarships for medical students to undertake rural placements each year.

But the Australian Medical Workforce Advisory Committee estimated Australia needed around 1,000 new GPs each year, Dr Capolingua said.

More here:

http://news.smh.com.au/national/170m-ripped-out-of-gp-programs-ama-20080519-2fx4.html

I doubt the AMA will give much rest to the Government on this apparent reduction in the e-health and primary care areas. On this I must say I agree. Re-distribution of funds to suit the Labor directions is fine – but cutting that much really is a concern.

Fourthly we have:

Hospitals creating ghost wards

Julia Medew and Jill Stark
May 19, 2008

OVERCROWDED Victorian hospitals are altering computer data and admitting emergency patients to non-existent "virtual wards" to meet State Government targets for bonus payments.

Leaked minutes from a recent meeting of the Australasian College of Emergency Medicine reveal that almost 40% of hospitals have been "admitting" patients when they are, in fact, still languishing in emergency waiting rooms, corridors or on trolleys.

The document also shows that more than a quarter of 21 hospitals surveyed by the college had changed figures to give the impression patients were being moved to beds within eight hours.

A doctor who did not want to be named told The Age the virtual wards existed only in cyberspace and were used purely for "creative accounting".

Public hospitals receive bonuses for reaching State Government benchmarks that require 80% of patients to be admitted within eight hours of arrival. Studies have shown that patient care is compromised by spending long periods of time in emergency departments.

More here:

http://www.theage.com.au/news/national/hospitals-creating-ghost-wards/2008/05/18/1211049067274.html

The fact that managers are being ‘economical with the truth’ and distorting figures shows just how much pressure the public hospital sectors around the country are. Really a sad symptom of the stress in the sector.

More on this is also found here:

Probe into 'virtual wards'

Julia Medew and David Rood

May 20, 2008

THE Victorian Government has launched an inquiry into allegations that public hospitals are creating "virtual wards" and altering computer data to receive performance bonuses.

Health Minister Daniel Andrews ordered the investigation yesterday after The Age revealed almost 40% of hospitals surveyed by the Australasian College for Emergency Medicine had been "admitting" patients when they were still languishing in emergency waiting rooms, corridors or on trolleys.

The survey of senior emergency department doctors from 19 Victorian hospitals also found that a quarter of the hospitals had changed figures to give the impression patients were being moved to beds within eight hours.

"No complaints have been made, no evidence has been put forward that would in any way support the claims that have been made," Mr Andrews said yesterday before announcing the Department of Human Services would look into the survey. "It is my expectation that every single health service will provide accurate data."

Continue reading here:

http://www.theage.com.au/news/national/probe-into-virtual-wards/2008/05/19/1211182704318.html

Fifth we have:

Deloitte takes on e-health records plan

Abstracted from The Australian Financial Review

The Victorian Government has contracted a consultancy to assist in developing a national electronic health records system. Deloitte Touche Tohmatsu is on a $A1.3 billion six-month contract to plan a strategy, which is backed by the National e-Health Transition Authority and will be presented to the Council of Australian Governments.

More here:

http://www.businessspectator.com.au/bs.nsf/Article/Deloitte-takes-on-e-health-records-plan-ERURX?OpenDocument

The URL of the full AFR article is here

http://www.misaustralia.com/viewer.aspx?EDP://20080519000020679302&magsection=news-headlines-home&portal=_misnews&section=news&title=Deloitte+takes+on+e-health+records+plan

It is really good to see the planning process has at last begun. Will look forward to see how it work out over the next few months.

More on this is also available here:

National e-health vision unleashed in September

By Suzanne Tindal, ZDNet.com.au

May 19, 2008

The Victorian government has hired Deloitte for AU$1.3 million to develop an Australia-wide e-health strategy.

The strategy is intended to provide a vision or recommended "future state" for e-health over both public and private sectors for the next five to 10 years, and give advice on what forms of governance will need to be put into place to manage it, according to tender documents.

To come up with the strategy, Deloitte will be delving into Australia's current e-health capability in all states, public and private, and the current effects of technology on healthcare. The state of international e-health will also form part of the report.

For more see here:

http://www.zdnet.com.au/news/business/soa/National-e-health-vision-unleashed-in-September/0,139023166,339289088,00.htm

Sixth we have:

Qld Health investigates electronic prescription system

Article from the Courier Mail

Darren Cartwright

May 20, 2008 12:00am

QUEENSLANDERS could have access to a new system that electronically delivers a doctor's prescription to any pharmacist in the state, similar to a scheme that has just been rolled out in the Northern Territory.

Queensland Health's chief information officer, Paul Summergreene, says the department is investigating the system and determining whether it will be introduced in the Sunshine State.

"We are actively looking at the efficiency, accuracy and speed of medication discharge information such as the electronic transfer of prescriptions," he told The Courier-Mail online.

The NT Government this month became the first state or territory to introduce electronic prescriptions.

Continue reading here:

http://www.news.com.au/couriermail/story/0,23739,23728828-3102,00.html

Looks like a bit of publicity seeking ‘me-to-ism’ to me following the NT announcements! I wonder how long they have actually been considering this.

Last we have:

IT security needs makeover: experts

Karen Dearne | May 20, 2008

IT's time to fundamentally rethink IT security, as industry heavyweights rule out passwords, patching and anti-virus software as well past their use-by date at AusCERT 2008 this week.

John Stewart, chief security officer of Cisco, told the conference new collaboration technologies are moving users into a truly information-centric world, yet “we're relying on the user to do the right thing”.

“Security professionals know that the most dangerous thing of all is the person operating the computer,” he said. “If you envision installing software without knowing its source, then making it part of how you share information - users have to know what to do to protect it.

“This is the space we're moving into - we're actually asking users to do much more than they've ever had to do before.”

Mr Stewart said patching is dead as a first line of defence, while the volume of malicious software circulating has overwhelmed anti-virus makers.

“Patching is problematic because companies rely on their infrastructure, and you can't have it offline to patch,” he said. “If I do have to patch, then I only want to do so in the restricted timeframes when I can take the system offline.

“Meanwhile, anti-virus is a signature technology, and it's mathematically impossible for the software vendors to keep up. Worse, malware is becoming harder to detect, because hackers actually want to keep the infrastructures running.

“Businesses instrument their networks for availability, so malware is no longer trying to disrupt. Instead, the intent is to steal information, and it's trying to do that very quietly because it wants to remain in your system as long as possible.”

More here:

http://www.australianit.news.com.au/story/0,24897,23730194-5013044,00.html

This was clearly an important conference with the core message being that internet security is getting very much harder. Obviously those with responsibility for keeping data safe and accurate need to carefully review the proceedings.

More information is available here:

http://www.auscert.org.au/

More next week.

David.

Why Does Qld Health Want to Have More Less Smart Children?

Sometimes you just have to be really annoyed!

The obfuscation coming from the Qld Government on the levels of lead in the blood of 1-4 years olds in Mount Isa is one of those situations.

Lead, in virtually any excess, causes a loss of potential mental ability in children. So why is it the Qld Government does not want to find out where the lead is coming from and how the children can be protected from it?

Can I suggest that this is just an obscenely uncaring and pathetic attitude that is to be totally and utterly condemned.

I bet if it were the children of the Qld Cabinet involved the inquiry and remedy would be virtually instantaneous. But some poor children of poor parents in Mt Isa compared with the continued mining and profits from Xstrata – no chance - profits win.

These kids are being given a lifelong sentence of not being ‘the sharpest tool in the shed’ because the Qld Government does not care. Obscene neglect is what I say!

Read more here:

Lead testing in Mount Isa rejected by Queensland Government

Michael McKenna | May 23, 2008

THE Queensland Government has refused to conduct extensive soil and water testing in Mount Isa despite its own study confirming that 11 per cent of children in the town have dangerously high levels of lead in their blood.

At the release of the final report of a blood-screening program of 400 children in the town, government ministers and officials said there was no need to conduct the tests and that the mine's owner, Swiss giant Xstrata, was already facing the repeal of decades-old laws granting it lower emissions standards than the rest of the state.

Instead, the Queensland Health report recommended that a "living with lead" alliance - made up of government, council and mine representatives - develop more "mitigation strategies" such as dust control and raising awareness of the problem.

The report released yesterday did not identify the cause of high levels of lead and other heavy metals discovered in children aged between one and four during the 14-month blood-screening program.

The screening program found that 45 of the 400 children had a blood lead level of 10 micrograms per decilitre. Australian and US studies have revealed that children with blood lead levels of over 10 micrograms per decilitre are at serious risk of learning and behavioural difficulties.

More here:

http://www.theaustralian.news.com.au/story/0,25197,23744269-23289,00.html

My view is a pox on all their houses for such horrible negligence. I hope the law suits cost the Government a squillion. After all, you can’t ever get your potential back once your brain is damaged by lead. Even one damaged child in one too many.

Back to Health IT on Monday.

David.

E-Prescribing – Do the Current Initiatives Make any Sense?

In recent times there has been a lot of discussion about electronic prescribing (or e-prescribing). In this blog I want to run through just what I believe would constitute a satisfactory e-prescribing system for Australia. The criteria I would apply are as follows.

Criterion 1.

The E-prescribing should be fully compliant with all aspects of AS 4700.3(Int)-2007 : Implementation of Health Level Seven (HL7) Version 2.5, Part 3: Electronic messages for exchange of information on drug prescription.

This would include electronic messaging of standardised content between prescriber and dispenser as well as support of the other medication management functions the Standard envisages.

Criterion 2.

The terminology used is the current version of the Australian Medicines Terminology (AMT) which in SNOMED CT compliant. This is a minor problem at present as I understand this is still a work in progress with a completion date somewhere in 2009.

Criterion 3.

The act of prescribing should be supported by Level 4 clinical decision support based on approved knowledge databases of established quality and consistency.

Criterion 4.

There be effective communication between dispensing and prescribing systems to enable assessment of issues such as compliance and medication abuse, while avoiding any leakage of such information to any third party without the agreement of the patient.

Criterion 5.

There be absolutely no access to prescription data by any commercial interests – most especially any pharmaceutical companies.

Criterion 6.

If any centralised ‘store and forward’ hub networking technology is to be used (as I would prefer) for allowing a prescription to be held until requested by a dispensing computer system then the hub should be controlled as a key piece of national e-health infrastructure by the Commonwealth Government (or a Government owned agency with appropriate governance in place to totally protect the public interest and patient privacy).

Criterion 7.

All access to the National e-Prescribing network should be fully protected by appropriate security, encryption and privacy mechanisms.

Criterion 8.

Access to the National e-Prescribing network should be via a fully open and standardised mechanism with an entity like Australian Health Messaging Laboratory (AHML) certifying compliance before access is permitted.

Criterion 9.

Of course, there should be only one national network with competition being encouraged based on the quality of the prescribing and dispensing systems offered by those who connect to the network.

At present there are three potential offerings in trial or in development on the table.

First we have the NT e-Prescribing Initiative.

Details of the approach being adopted can be found here:

http://publishing.yudu.com/Freedom/Acqew/Pulse+ITMay2008/resources/index.htm?referrerUrl=

(at page 11)

Or here:

http://www.health.nt.gov.au/news/2008/news_14_05_nt_delivers_national_first_electronic_prescriptions.shtml

Second we have the commercial ScriptX initiative.

Details of this can be found here:

http://publishing.yudu.com/Freedom/Acqew/Pulse+ITMay2008/resources/index.htm?referrerUrl=

(at page 17)

Or here:

http://www.corumhealth.com.au/news-detail.aspx?cid=1&navid=-1&newsid=24

Lastly I am assured that Medicare Australia has been considering how it might get into this space to augment their on-line presence and leverage the data they already hold.

I will leave it as an exercise for the reader to see how close each of these might be to what I believe is desirable.

Essentially I believe we should have a National E-Prescribing infrastructure that is open, fully standardised, fully SNOMED CT based system with hub controlled ultimately by Government.

Competition should be at the prescribing and dispensing client level. Trials of half-baked systems have their place – but they will not lead to the national infrastructure we need.

This is a project Government should support soon so we don’t wind up with a mess of incompatible and non-standardised systems.

David.

EHR Impact – An Important Study of Approaches to e-Health Benefits.

As part of the recent e-Health conference in Slovenia the following study was presented. Here is an interview related to the presentation.

“The main lesson is that ICT is only part of the solution”

At the recent European eHealth Conference in Slovenia, an EU commissioned study on the “Socio-economic impact of interoperable electronic health records and ePrescription in Europe - EHR Impact” was presented. One of the case studies is the computerised patient record (CPR) system at the University Hospitals of Geneva (HUG), which since 1998 has connected their seven hospitals at four campuses. Based on a service oriented architecture and utilising web technologies, it comprises unique patients’ and providers’ identification, access management, unified clinical documentation, order entry for all orders such as laboratory and radiology tests, and management information. HealthTech Wire talked to Prof. Dr. Christian Lovis, Head of the Clinical Informatics Unit at HUG, and Alexander Dobrev, consultant at the research and consulting firm empirica, about the impact of the CPR system on the hospitals.

- (HealthTech Wire) - Based on your initial research results, what are the major benefits of the CPR system for the hospitals?

The major benefits come from the redeployment of resources, including doctors’ and nurses’ time, leading to better quality care; a reduction of risk exposure; and avoidance of over-prescribing laboratory and radiology examinations. The hospital management also uses the system to provide important information for strategic decision-making. Health insurances benefit from fewer hospital admissions, because, e.g., patients in Accident & Emergency departments can often be helped immediately and need not become inpatients until their records are found. HUG also redeploys liberated resources to meet increasing demand.

More difficult to measure, but extremely important, are the benefits to the people involved. All clinical staff have to adapt to changing work flows and processes, and the gains must be of higher value than the extra effort required. We know from our interviews that these personal benefits include being able to focus on clinical tasks instead of searching for records, not having to chase colleagues to decipher illegible handwriting, and the feeling of being less vulnerable and exposed to risks, because the CPR system allows for better-informed decision making. There are gains to patient safety and quality of care – the CPR system provides doctors and nurses with the critical information and decision support they need to reduce the risk of adverse events, and it does so fast, so carers can pay more attention to individual patients.

Has the study shown a return on investment?

The EHR IMPACT study focuses on comprehensive benefit cost analysis, not on return on investment to a single stakeholder. These are different measures, but should be regarded together by decision makers. According to our research, based on accounting data and well-founded estimates, the value of economic benefits at HUG exceeded the value of economic costs on an annual basis for the first time in 2005. The cumulative turning point is achieved about now – 2007/2008, some ten years after the idea for the system in its current form was born. The analysis of the purely financial position is not yet complete but the preliminary results look promising.

More here

http://www.healthtechwire.com/Pressrelease.146+M5b4ee4b5902.0.html

The ongoing project has a web site which can be found here:

http://www.ehr-impact.eu

As part of these studies two evaluations have already started. These are the computerised patient record system at the University Hospitals in Geneva, Switzerland, and the Scottish Emergency Care Summary Programme in the UK.

Presentations on the Geneva project are already available here:

http://www.ehr-impact.eu/downloads/documents/2008-05-07%20eHealth%20Portoroz%20Lovis.pdf

and here

http://www.ehr-impact.eu/downloads/documents/eHealth_2008_Portoroz_dobrev.pdf

These were presented at the conference referred to earlier in the blog.

These presentations and the various papers provided at http://www.financing-ehealth.eu/ deserve careful review by all those interested in justification of e-Health investment.

David.

An Important Conference You Have Never Heard Of!

Earlier this month there was a small conference in Portoroz in Slovenia. The introduction to the conference describes it thus:

“The conference is the continuation of a tradition of annual ministerial or high-level events. These conferences enable the demonstration of contemporary achievements in eHealth and the set-up of guidelines for future efforts so as to ensure the efficient use of information and telecommunication solutions in healthcare.

eHealth has enabled a tremendous development of healthcare systems over the last few years. It has already brought many opportunities to raise the quality and accessibility of healthcare services. It provides a greater efficiency of services which, in today’s era of considerable expectations on the part of every citizen, combined with limited financial resources in the system, has become among the most important goals of healthcare. With the help of information and telecommunication technologies we are introducing new ways to provide medical treatment, ease communications between citizens and healthcare providers, simplify procedures, ensure mechanisms for reducing errors, encourage individuals to manage their own health and, finally, provide data for the management both of risks and healthcare systems.”

The conference web site can be found here:

http://www.ehealth2008.si/

What came out of the full 2 day meeting was the following declaration.

The Portorož Declaration
7 May 2008: eHealth 2008 Conference Declaration

eHealth in a Europe “without frontiers”: Building New Initiatives - Working Together

The potential offered by eHealth, and the evidence of its success, has long been clearly identified. Since 2003, with the creation of a series of eHealth conferences of which this is the sixth various Ministerial and high-level groups, together with the European Commission, have agreed to making Declarations and conference conclusions with a focus on eHealth. Based on these yearly commitments, the Member States have achieved a great deal of progress. Their successes include eHealth roadmaps in all 27 of the Member States, in-depth involvement in the large-scale pilot on eHealth, and considerable penetration in many different countries of the use of electronic health records, much of this based on direct implementation of the eHealth Action Plan for a European eHealth Area.1

People-centred eHealth initiatives provide all Europe's citizens with smarter health environments. They aim to satisfy the need to provide 'the three Cs' continuity of care, comprehensiveness (and integration and coordination) of care, and care in the community to Europeans. Citizens and patients are enabled to become actively and dynamically engaged in the actual process of healthcare and on their own personal health needs. Today, we go several steps further in applying all these agreed goals, advancing them further by:

• Building on national eHealth roadmaps

Each Member State has shared with the others its recent plans and strategies regarding policy priorities in eHealth. Commitment is needed to ensure that roadmaps are updated and distributed regularly, to maintain a solid foundation for building future activities. Information should also be disseminated by the Member States regarding the kinds of electronic tools that can support them in addressing the many, concrete challenges posed by health care systems.

• Organising Europe-wide cooperation

In the context of a project supported by the Commission, a consortium of Member States and industrial stakeholders has committed to developing, designing, prototyping, and validating in a pilot context European Union electronic health services based on two distinct health situations: cross-border access to electronic patient summaries and ePrescription (including e-medication). Other Members of the Union and stakeholders are involved in a “watching brief” of this pilot, through which they understand and assess in what ways they can use the applications that are under development. This Union-wide cooperation will continue to evolve over a 3-year period.

• Combining standardisation and safety in eHealth

The Commission plans to issue a recommendation on cross-border interoperability of electronic health record systems, laying out clear guidelines for arriving at the keenly anticipated scenario of enabling patients to access electronic health records anywhere any time. There is a need to emphasise the improvement to patient safety that ICT can facilitate, especially as a result of the enhanced interoperability of systems. Combining standardisation and safety in eHealth must now be seen as a priority issue by all stakeholders. It is fundamental to define a common understanding through semantics in healthcare.

• Involving all stakeholders, in particular patients, and supporting the eHealth industry, especially small- and medium-sized enterprises

Participation of industry in the planned large-scale pilot on cross-border use of patient summaries and medication data is particularly welcome. The paradigm shift towards clear support for eHealth can be achieved only by involving the key industrial and user stakeholders in developing eHealth solutions from the earliest stage. Industry and user stakeholder groups will continue to be consulted regularly during the formulation of policy in the eHealth field.

• Creating an innovative eHealth market

With its focus on deployment-related implementation, the Commission Communication on 'A Lead Market Initiative for Europe'2 outlined barriers to the development of the eHealth market in Europe. The Communication included specific actions for Member States to contribute to accelerating the development of the market, including support for further pilot actions under the Competitiveness and Innovation Programme and a coordinated action that will relate to possible developments in the legal framework, standardisation, certification and procurement activities.

Building the key next steps - three core and parallel endeavours

Three key initiatives must now begin to operate harmoniously alongside each other in order to overcome the major health challenges that lie ahead over the next ten-year period.

• The first crucial area is the need to plan to deploy telemedicine and innovative ICT tools for chronic disease management. The Commission aims to issue a Communication on this topic in the fourth quarter of 2008. Its objective will be to enable Member States to identify and address possible barriers for wider deployment of telemedicine and to coordinate their efforts.

• Second, but equally important, is the need to introduce an enhanced focus on new research opportunities. A more adventurous exploration of next and future research and technology development steps in Europe is required. Government policy-makers should look ahead in a prospective foresight and envisioning exercise. Thus, they will understand how exciting new directions in research and development are likely to affect policy decisions about health care decisions over a ten-year time horizon, and start to plan for such innovation potential. Citizens’, patients’ and health professionals’ involvement will be key to this process, as well as for the success of present-day implementation of projects.

• Third, is the need for a transparent legal framework agreed between the Member States. It would help to define the responsibilities, rights and obligations of all the different subjects involved in the eHealth process, such as national, regional and local health authorities, health care professionals, patients, insurance companies, and other relevant players. Special attention should be paid to exploring the existing Community legislation that affects eHealth significantly, especially the Data Protection Directive, e-Privacy Directive and e-Commerce Directive. This implies an active dialogue and involvement of all the relevant national authorities in the area of health, personal data protection, technical harmonisation, standardisation, and eCommerce.

Getting on board today: the immediate big step that will enhance the quality of health and social care for over 500 million Europeans

The Member States and the European Commission commit to support together the deployment of high-capacity infrastructure and infostructure for health and social care information networks and services such as telemedicine (teleradiology, teleconsultation, telemonitoring, telecare), ePrescription and eReferral. With continued commitment from all the actors involved, European-wide cooperation on electronic health services will lead to the successful formation of a European health information area. As a result, the health of European citizens and the sustainability of European health care systems will benefit considerably.

1 COM(2004)356: eHealth - making healthcare better for European citizens: An action plan for a European eHealth area.

2 COM(2007)860: A lead market initiative for Europe.
The declaration is found here:

http://www.ehealth2008.si/index.php?id=26&mid=25

So what we have here are the 27 countries of the European Union (many of which are less than 20 years from being under the yoke of the former USSR) recognising that after a decade of investment they are really starting to get places and committing both more effort and more investment at the top strategic level.

I wonder will we see a comparable vision and commitment from the current National E-Heath Strategy process and the new Federal Government. The early signs from the recent budget hardly fill one with confidence.

One really wonders why it is so hard in Australia!

David.