Day: October 25, 2007

Medsphere Settles with Cofounders

For those of us interested in new business models and open source software, Modern Healthcare has a nice overview story the evolving relationship between Medsphere and the open source movement. On June 26, 2006, Medsphere filed a $50 million, 12-count lawsuit in Orange County (Calif.) Superior Court against the Shreeves and 20 other unnamed defendants, alleging - among various complaints - misappropriation of trade secrets, breach of contract, breach of duty of loyalty, violations of the Racketeer Influenced and Corrupt Organization Act, commission of computer crimes, intentional interference with contract relations and unfair competition. The Shreeves' employment at Medsphere also was terminated, though Steve Shreeve remained on the board. In November, the Shreeves filed a countersuit against the company, its then-CEO and board chairman, Kenneth Kizer, and other officers. At issue was the posting in early June of Medsphere computer code to, a popular Web-based platform for open-source development projects. At the time, in addition to his position on the board, Steve Shreeve was the company's chief technology officer and Scott Shreeve was its chief medical officer. You can read a history of the company that Steve Shreeve, posted here after the Medsphere lawsuit against him and his brother was filed. Brother Scott Shreeve said after the settlement, "We hope he (new Medsphere CEO, Michael Doyle) has the freedom and wisdom to run it as a true, open-source...

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Is Microsoft HealthVault Safe?

Many have criticized HealthVault regarding privacy and security concerns, or perceived limitations of HV as a personal health record (PHR). I suspect that HV is challenged more by the market's perception of Microsoft's long running security issues than with any actual shortcomings of that type in HV. And since HV is not a PHR, but rather a "platform," criticisms about any lack of PHR features is not relevant. One topic I've not seen addressed is the safety and effectiveness of the data within HV - and I don't mean "safety" as in the data is secure from unauthorized access or misuse. I mean "safety" as in the utilization of data stored in HV by other applications won't result in an unsatisfactory patient outcome, you know, like death or injury. Certainly at first blush HV does not fall under the FDA's purview, but things could end up that way. (More on this later.) A key tool mandated by the FDA's Quality System regulation (QSR) to ensure quality and safety is the risk analysis. Any kind of connectivity needs to be thought of with risk analysis in mind - what can go wrong and how can those risks be mitigated? If HV is more than just an interface engine, pushing data from one application to another, the risks are narrow. Sample risks include: data corruption during transfer into or out of...

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