Describing the effort as "a revolution in health and care information," the UK government last month announced a program intended to result in every National Health Service (NHS) patient in England having an electronic care record by the end of this decade. British Telecom (BT) was awarded a 10-year contract to set up and run the national NHS Care Records Service. Under that contract, valued at 620 million, BT will provide the infrastructure for a service that will provide 50 million persons served by the NHS with an individual electronic patient record.
Those records will outline treatments and care received under either England's health or social care programs, and for the first time such information will be mobile, like the patients themselves. The NHS Care Records Service will connect more than 30,000 general practitioners and 270 acute, community and mental health NHS trusts in a single national system.
In announcing the program, Health Secretary John Reid said, "The NHS Care Record will completely revolutionize the way that information is accessed and will make available efficient, secure and integrated records to the right people at the right time." He added that patient records "will be available 24 hours a day, seven days a week to ensure that vital information about an individual's health and care history can be available instantly to health professionals who have authorized access." Reid said this "will be of particular use to Accident and Emergency staff, who can access information about emergency patients and help to diagnose them more quickly."
Citing the vast number of existing paper- and computer-based records that cannot be quickly transferred around the system, Reid noted: "Our hospitals hold millions of paper records that have to be manually retrieved when patients need treatment or see a consultant. In the 21st century, this is clearly not an efficient way to store health information."
He said the NHS Care Records Service "is a key part of reform of the NHS and will help make [it] a truly responsive service which provides patients with more choice." In order to help patients make such choices, Reid said they would need access to "more information about the NHS and their own personal health and care history than ever before. This system will equip the NHS to provide that." The care records also are expected to cut down on time wasted by NHS staff and patients who arrive for appointments only to find that their records are not ready or are in the wrong place in the hospital or clinic.
The design and rollout of the NHS Care Records Service has been organized into two parts, with services that are common to all users nationally being the responsibility of BT, the national application service provider (NASP). Services delivered at a more local level will be the responsibility of five local service providers (LSPs). The NASP and the LSPs will make information technology work across the NHS to support the creation of the records service. England's strategic health authorities have been grouped into five implementation groups known as clusters, set up to ensure that the national applications can be delivered locally, while maintaining standardization.
Two additional contracts have been awarded to LSPs for the North East and London regions, covering the delivery of both the NHS Care Record and the Electronic Booking Service, which was announced last October. British Telecom received a 10-year contract valued at 996 million to provide systems to access and use the service and IT support at a local level in the London region. Accenture (London) was awarded a similar contract, worth just under 1.1 billion billion, to provide systems to access and use the service and IT support at a local level in the North East region. Additional LSP contracts were to be awarded by year-end for the remaining service regions: North West and West Midlands, Southern and Eastern.
Wound management unit for IsoTis
IsoTis OrthoBiologics (Lausanne, Switzerland) has established EpiSouce as an independent unit and a potential spin-off company for the IsoTis wound management portfolio. The company said EpiDex, Allox and AcuDress, the three products that constitute the EpiSource portfolio, all have achieved major milestones. Reimbursement of EpiDex, a solution for the treatment of recalcitrant skin ulcers, was approved by the Swiss agency OFAS for an initial period of two years starting Jan. 1. EpiSource said it intends to commercialize EpiDex in Switzerland through an independent distribution channel.
Patient recruitment for a Phase II dose escalation trial for Allox was completed last fall. Data analysis is anticipated for June, with an investigational new drug application filing with the FDA anticipated by September 2004. Allox is the subject of a deal with HealthPoint Ltd. that was concluded last August, with HealthPoint assuming further clinical and commercial development of Allox once the IND filing is approved. AcuDress, a burn wound treatment, has been transferred from its previous production location in Bilthoven, the Netherlands, to EpiSource in Lausanne, and will be manufactured and shipped from there.
Jacques Essinger, chief executive officer of IsoTis Orthobiologics, said, "With EpiDex reimbursed, AcuDress on the market and Allox meeting its critical milestones, the commercial value of the pipeline of EpiSource is materializing, giving it an excellent position to seek partners in Switzerland to further advance its business potential."
IsoTis OrthoBiologics was created last November through the merger of GenSci OrthoBiologics (Irvine, California) and IsoTis SA (Lausanne). It has about 150 employees, a portfolio with six orthobiologics products on the market and nine others in development, pro forma product sales of $23 million, and an established North American independent distribution network of 400 sales representatives. The company is focused on the market of orthopedics and bone graft substitutes. It is developing a broad presence in both natural demineralized bone matrix products and synthetic bone graft substitutes, carrier technologies and biologically-based growth factors.
Inamed breast implants reclassified
The single-lumen model of Inamed's (Santa Barbara, California) silicone gel-filled breast implants has been certified as satisfying the European Union's (EU) safety and efficacy requirements for the most stringent classification, Class III Medical Device, the company said. The reclassification came three months ahead of the March 1, 2004, deadline to continue sales of the breast implants in the EU.
Nick Teti, chairman, chief executive officer and president of Inamed, said of the reclassification of the implants into the strictest category of medical devices for sale to the public: "We are gratified that these products have been determined by scientific review in the EU to be safe and effective."
Inamed said that four of the models and styles of breast implants that satisfy the EU's Class III certification requirements McGhan Styles 40, 45, 110 and 120 are the same implants that are currently under premarket approval review in the U.S. by the FDA. The FDA's General and Plastic Surgery Advisory Panel recommended in mid-October that the agency approve, with conditions, the general marketing of Inamed's silicone gel-filled breast implants in the U.S. A decision by the FDA is pending.
Collaboration on prion disease tests
Proteome Sciences (Cobham, UK) reported a collaboration with the UK Medical Research Council to identify differential protein expression in the prion diseases Creutzfeldt-Jacobs disease (CJD) and vCJD, as the basis for diagnostics and treatments. The company also said it was awarded a U.S. patent on the use of annexin proteins as serum markers for diagnosing lung, breast and esophageal cancers. Antibodies to those proteins occur in the blood of patients with tumors, but not in healthy individuals.
Proteome said it is looking for partners to co-develop diagnostic tests.