A Medical Device Daily

New rules unveiled last month by UK Health Minister Lord Warner are aimed at insuring that patients keep control over access to their health records in National Health Service (NHS) databases scheduled to be launched next year.

The Care Record Guarantee sets out the rules governing information held in the NHS Care Records Service, a nationwide patient health record system that will begin rolling out across England next year.

Among the commitments the Guarantee makes to patients about their records are that access to records by NHS staff will be strictly limited to those having a “need to know” to provide effective treatment to a patient.

And eventually patients will be able to block off parts of their record to stop it being shared with anyone in the NHS, except in an emergency. Warner said that individuals will even be able to stop their information from being seen by anyone outside the organization that created it, even though doing so may have an impact on the quality of care they receive, Warner said.

“The new electronic record system has enormous potential benefits for patients,” he said. “In time, it will allow staff caring for them – wherever they may be in England – to have instant, accurate access to their essential health history, including allergies, current medication, pre-existing conditions and recent treatment.”

Noting that there will be “very strict controls” on who has access to a patient’s records, he said, “These rules will be backed up with tough security measures to prevent unauthorized access to records, ensuring [that] everyone can have confidence in the new system.”

The NHS Care Records Guarantee was drawn up by the Care Record Development Board (CRDB), an advisory body of patients, members of the public, healthcare professionals, social workers and researchers. It is chaired by Harry Cayton, national director for patients and the public in the Department of Health.

The document covers patients’ access to their own records, controls on access by others, how access will be monitored and policed, options people have to further limit access, access in an emergency, and what happens when someone cannot make decisions for themselves.

Research undertaken with patients and the public in 2002 by the NHS Information Authority with the Consumers Association showed what the Department of Health described as “a high level of trust in the NHS,” but also a concern about who uses the information in patients’ health records. “When asked what would provide reassurance that the NHS is careful with health information, the most commonly mentioned safeguard was a published sharing agreement,” the department said.

So the Care Records Guarantee was developed through wide-ranging consultation with patients, the NHS and other interested parties. It was further refined by a Public Advisory Board of people from patient, carer and citizen groups in consultation with the Department of Health’s Patient Information Advisory Group and finalized by the CRDB. The latter group will review the guarantee every six months and update it as the NHS Care Records Service develops.

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, secure national service. The service is intended to replace the existing variety of local paper and computer-based record systems.

EDAP cites efforts at AUA

EDAP TMS (Lyon, France) said it successfully continued its education efforts relating to high-intensity focused ultrasound (HIFU) technology in combating prostate cancer during last month’s American Urological Association (AUA; Linthicum, Maryland) meeting in San Antonio.

Three abstracts relating to the efficacy of HIFU as a treatment option were presented by Dr. Albert Gelet of Edouard Herriot Hospital (Lyon), Dr. Stefan Thueroff of Harlaching Hospital (Munich, Germany) and Professor Christian Chaussy, also of Harlaching Hospital.

Gelet’s abstract outlined an 86% success rate and “substantially lower” side effect rates in a five-year study of 230 patients treated with Ablatherm HIFU. Thueroff reported results of more than 1,000 treatments at a single center confirming high efficacy – up to 93% as measured by negative biopsies – and low side effects on high-, medium and low-risk groups of patients. Chaussy reported on side effects at eight years, showing low side effects of local Ablatherm HIFU in primary cases.

At the AUA meeting, EDAP introduced its newest enhancement to the Ablatherm integrated imaging system – a probe that allows users to obtain a high-quality 3-D image while simultaneously treating the patient. That significantly shortens treatment time and offers increased imaging capability, the company said.

Trial boosts colon cancer ‘keyhole’ surgery

A 10-year trial by British researchers and reported in The Lancet last month found that keyhole surgery appears to be as effective as open surgery for colon cancer.

Dr. Pierre Guillou and other researchers at St. James Hospital (Leeds, UK) reviewed the results from 730 patients with colorectal cancer, 253 of whom received open surgery, 484 of whom received keyhole surgery, and 143 patients who underwent conversion from keyhole to open surgery.

Guillou reported that the risk of recurrence and of complications appeared to be about the same for the two types of procedures.

In the open procedure, surgeons remove a section of the intestine around the tumor. In the keyhole procedure, doctors use a small camera inserted through a 5 cm incision to excise the tumor.

While keyhole surgery has become common in many types of procedures, it has seen limited use for colon and rectal cancer. According to a United Press International report, an accompanying note in The Lancet from Myriam Curet of Stanford University (Palo Alto, California) said that Guillou’s findings show that keyhole surgery may become the new “gold standard” for colorectal cancer patients who are ”appropriately selected and operated on by experienced surgeons.”