PHARMACY

Dossia to make health records available to founders’ employees

BY Drew Buono

ORLANDO, Fla. According to Dossia chief technology officer David Hammond, the electronic health records consortium is planning to make its Web-based system widely available to employees of its founding members later this year, according to published reports.

Members of Dossia include Wal-Mart, Intel, Cardinal Health, AT&T, Applied Materials, BP America, Pitney Bowes and Sanofi-Aventis.

Hammond said that the consortium also has started trying to entice other employers to join the group. And in the spring, Dossia plans to publish an Application Programming Interface for the system and accelerate its efforts to get health care providers to agree to input the medical records of patients.

He also acknowledged that the health records system “is still in a formative stage.” But he vowed that the technology will work, and claimed that it will improve the ability of patients to manage their own health care by giving them a central storage point for their records, which they then will be able to share with multiple doctors.

The system being built by Dossia “is sort of like a virtual shoe box that you can save all your medical records in and cart around with you,” Hammond said. “We’ve left this [data] in the hands of medical professionals for so long. We need to give some of that control back to [patients].”

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PHARMACY

FDA to review ulcer gel, HIV medications

BY Drew Buono

WASHINGTON The Food and Drug Administration is conducting two safety reviews of the drugs Regranex gel, used for leg and foot ulcers and the HIV medications Ziagen and Videx.

Diabetic patients using Johnson & Johnson’s Regranex face an increased risk of cancer from using the gel.

Data analyses from another study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking GlaxoSmithKline’s Ziagen or Bristol-Myers Squibb’s Videx as part of their drug therapy.

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FDA OKs Dendreon’s phase III Provenge trial

BY Drew Buono

SEATTLE The Food and Drug Administration has agreed to allow Dendreon to get the final results from its phase III trial for its prostate cancer drug Provenge.

Last May, the FDA requested additional clinical data from Dendreon to support its effectiveness claim for Provenge despite a vote by the Cellular, Tissues and Gene Therapies Advisory Committee in favor of approving the drug. The committee voted 13 to 4 that the product was effective and 17 to 0 that it was safe.

That request led three congressmen: Reps. Mike Michaud, D-Maine, Dan Burton, R-Ind., and Tim Ryan, D-Ohio, to point accusations that conflicts of interest on the advisory committee might have led some of its members to send written requests to the FDA asking that the drug not be approved. One of the members of the committee is a lead investigator for a competing cancer drug made by Novacea.

According to the company, interim results from the IMPACT study of Provenge still are expected later this year, but final results are now expected in the second half of next year rather than the second half of 2010.

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