Medical Device Daily and Staff Reports

The dossier médical personnel (DMP) is dead. Long live the dossier médical partagé (DMP).

Following a scathing report that all but killed the French national e-health program, a follow-on plan to re-launch the program submitted six months later by the same inter-ministerial task force has been endorsed and funded by the Health Ministry.

The most significant change is lifting the accent on a "personal" health record, which could only be unlocked with a patient's e-health card and code, and instead shifting the informatic architecture to a dossier "partagé," or shared record, which can be accessed by all health professionals, the government, and likely private payors.

To no one's surprise, the doctors won their fight for access to, if not control of, the electronic record.

With a generous three-year pilot period and a vague estimation of 2011 as the date when French citizens will be able to use the re-launched system, it may be a long time before anything is reported again on what was once proclaimed to be the "magic button" that would fix the dysfunctions in France's health system and relieve the increasing financial burden.

Far more sober and "réaliste" than the first announcement of the program in 2004, the new plan describes formidable technological barriers and takes into account the treacherous legal ground the program will cross by creating inter-ministerial groups to tackle the thorny issues.

At Hospital Expo, held in Paris the final days of May, Jacques Sauret, chief executive of the DMP organization, the Groupement d'Intér t Public DMP (GIP-DMP), said he continues to believe the program could technically be up and running in three years, possibly two, but that working through the "change issues" is going to take considerably longer.

In late May, Health Minister Roselyne Bachelot endorsed the 120-page report submitted by Michel Gagneux, the Inspector General of Social Affairs, and reported the annual budget would be set "between 130 million [and] 150 million" ($46 million to $77 million).

Some 20 regional pilot projects will be developed over the next three years, building on programs started under the previous program, and significantly, these projects will share the seemingly simple goal of demonstrating a secure exchange of patient identification numbers as a first step.

At Hospital Expo, the GIP-DMP showcased three regional projects — showing interoperability of lab records in Aquitaine, dynamic links between general practitioners and hospitals in Picardie, and patient identification on Réunion, the French island in the Indian Ocean.

The right of French citizens to see and control their personal medical data is a hard legal issue that cannot be made to go away with ministerial reports and commissions. The right to control of personal data is encoded in French law and enshrined in the European Union treaty.

Control is interpreted in the French program as an ability to mask certain data, at the discretion of the patient, and to the consternation of doctors.

The newly launched DMP program tip-toes around the issue and concludes that some other task force will need to reconcile this personal right with the medical requirement for shared information.

First private British clinic to offer e-health records

Adding fuel to the argument that England's National Health Service (NHS) should return control of electronic health systems to the local level, healthcare provider Westover Medical (London) said it will offer an electronic history to the patients of its chain of primary healthcare clinics.

Patients can use the card from any computer, anywhere in the world, to access records stored by Westover Medical through a secure web site.

Westover is the first private healthcare provider in the UK to offer an electronic key card to access medical records and the company promotes the benefit of transportable medical histories for patients with complicated medical conditions who travel abroad or for students going to university.

Westover operates clinics in South Kensington, Wandsworth and this month is opening a clinic in Notting Hill.

For its public health service, the UK has struggled to put in place the Connecting for Health (CfH) electronic patient record system and no other private provider has so far dared to step into the path of the slow-moving but massive NHS machinery.

On the heels of the apparently mutual decision for Fujitsu (Tokyo) to quit the Connecting for Health program, a member of the House of Commons Public Accounts Committee criticized the over-ambitious and long-delayed implementation of a national system, saying, "The original approach of handing over monopolies to a handful of local service providers was never going to work and has been shown not to work."

E-Health Insider reported that the shadow health minister of the opposition Conservative party, Stephen O'Brien, said: "The government's attempts to ram through a top-down, centralized, one-size-fits-all NHS supercomputer system have come crashing down. This is 12.7 billion of taxpayers' money now at risk."

1st patients enrolled in TAAMI trial

Spectranetics (Colorado Springs) reported enrollment of the first patients into its ThromboAblation in Acute Myocardial Infarction (TAAMI) trial. The trial is a planned 200-patient randomized trial involving major medical centers in Poland.

Starting last quarter, TAAMI enrolled its first six patients and recently initiated the fifth participating hospital.

The trial comprises two treatment groups and enrolls the most complex acute myocardial infarction (AMI) patients – those with a large thrombus burden presenting with ST wave elevation myocardial infarction (STEMI). The study group receives excimer laser treatment plus direct stenting. The control group receives balloon angioplasty and stenting.

The primary endpoint is a combination of ST resolution, which is resolution of the EKG ST wave elevation injury pattern and the amount of distal embolization as measured by myocardial blush scores.

The principal investigator of the TAAMI trial, Dariusz Dudek, MD, PhD, a cardiologist at the Jagiellonian University Medical Center (Krakow), said, "This trial will help to assess the effectiveness of laser treatment in conjunction with stenting, and in comparison with a common current combination treatment."