Medical Device Daily and MDDs

Germany's largest private health insurance provider, Barmer Ersatzkasse (Wuppertal, Germany), is launching the world's largest roll-out to date of personal health records (PHRs) in order to study the effect on the health behavior of policyholders.

Starting this fall, 7 million German citizens insured by Barmer will be offered, progressively, access to a web-based LifeSensor PHR created by InterComponentWare (ICW; Walldorf, Germany). "The insured themselves can best evaluate the advantages and benefits of a personal health record and provide tips for its practical use," said Birgit Fischer, deputy chairperson of the managing board at Barmer.

She said the plan will expand what has until now been primarily technical discussion about PHRs to include the implications of applying the technology to the insured and patients under treatment.

The announcement by Barmer marks a milestone in a groundswell shift in Germany where insurers have become impatient with the long delayed, and much-troubled, state-sponsored program for PHRs, the elektronische gesundheitskarte (eGK), or patient electronic health card.

Several organizations in Germany, including private health insurance companies and regional health authorities, reported plans over the summer to independently create electronic patient records, creating concern that a lack of uniform standards will be problematic later, according to Financial Times Deutchland.

ICW, meanwhile, has simultaneously launched a campaign in the U.S. to jump-start the roll out of PHRs and it is importing the European mandate for patient control of records as a strategy to differentiate its offering.

At the end of July, Gen. Norman Schwarzkopf, host of Health Journal Television on CNBC, discussed ICW's vision of a PHR as the driver that will transform healthcare delivery in the U.S.

CEO Peter Reuschel said the ICW approach is radically different for the U.S. market because the patient controls access to medical data.

By owning their health information, he said, patients can take active measures in their health and wellness and influence the outcome of their treatments.

In August, the company launched the U.S. version of its web-based LifeSensor PHR that enables patients to exchange and manage health data with their providers.

ICW also is introducing to the U.S. one of several chronic disease management and health and wellness programs called LifeSensor Diabetes, an add-on package to the LifeSensor PHR.

On the Health Journal program, Reuschel said, "a PHR alone doesn't make much sense. It's really about the integration of a PHR with other information systems which are already in place."

ICW has been developing its health information platform in conjunction with the Heidelberg University Hospital near company headquarters in Walldorf to overcome the hurdles of information standardization that remain the most formidable obstacle for any PHR project. (Medical Device Daily; May 4, 2007).

Also appearing with ICW on the Health Journal program was Dr. Charles Eaton, director of Brown University's Center for Primary Care and Prevention at the Memorial Hospital of Rhode Island (both Providence), who is leading a project for ICW to create a "virtual medical home."

The center's project will connect LifeSensor PHR with the electronic medical records so that patients can control records.

The Barmer program for Germany adheres strictly to the tight controls in that country for personal data. The health insurance provider will not have any access to the health records of individuals insured, nor will physicians, pharmacists, clinics and other providers of health services. The policyholder alone can grant access to his or her health data.

IVD pact between Biovator, AstraZeneca

Biovator (Stockholm, Sweden) and AstraZeneca (London) have signed an agreement for the development of an in vitro diagnostic test that identifies potential allergens.

The companies noted that allergic reactions to compounds found in new pharmaceuticals, cosmetics and foods are a risk that needs to be discovered in advance, "but until recently, this could only be determined by animal testing," they said.

For several years Biovator, often with support from AstraZeneca, has been refining an in vitro method to take the place of what the companies referred to as "expensive and ethically questionable animal testing."

The new test is expected to be ready by 2009, which also is when the European Union will forbid the use of animals in the determination of risk for allergic reactions.

"We're definitely seeing a ground swell of enthusiasm and interest in our method as a substitute for conventional testing on animals," said Stan Mikulowski, CEO of Biovator "Working together with AstraZeneca helps us exchange valuable skills and experience, and we see this as a crucial step in the creation of new products to meet the coming EU directives."

CE mark for Endogun device

Endogun Medical Systems (HaOgen, Israel), a manufacturer of solutions for minimally invasive fastening of soft tissue, reported receiving the CE mark for its single-incision, trans-vaginal EndoFast Reliant device for repair of pelvic organ prolapse and stress urinary incontinence (SUI). Endogun was granted FDA clearance a year ago to market the EndoFast Reliant for soft-tissue attachment.

CEO Elad Naggar said, "The CE mark is a key milestone toward bringing our prolapse and SUI product to market. We believe that our solution may have significant advantages over what is available today, for patients, physicians, payers and providers. Endogun has a simple procedure which may improve safety and reduce the overall costs associated with prolapse and SUI repair."

Pelvic organ prolapse occurs in women, often following multiple births or excess weight, and develops as a result of weakening of the pelvic muscles which support internal organs (womb, bladder, rectum and vagina). Side effects of this condition include discomfort, a feeling of heaviness, and pain and the disorder carries the risks of inflammation and infection.

About 500,000 procedures are performed annually in the U.S. and Europe combined, with direct costs of associated surgical equipment reaching hundreds of millions of dollars, according to Endogun. Estimates suggest that close to 7 million women are in need of such treatment.

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