Connectologist Tim Gee considers patient safety and HealthVault:
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 HV, and data corruption during conversion of the data from one standard format into another. Mitigating these risks is straight forward; common data communications techniques to ensure data quality, and design and testing of the HV platform itself to verify data conversions are done accurately and reliably.
What if HV is more than a translator, but a repository of patient data? Most applications have a database that is written, updated and controlled by that application. It is the application that ensures that the data in the database is correct and valid. It is the application that provides the workflow to safely and reliably validate, edit and update data.