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Standards & Regulatory

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 […]


FDA Raises Bar on Medical Device Software Testing

Blog Medical Devices Today did a post last week on the FDA’s adoption of a relatively new software testing technology in the CDRH’s software forensics lab.
In the past year or so, the forensics lab, housed within the Office of Science and Engineering Laboratories, has used high-power instruments and techniques to analyze “source code” in roughly […]


42 Questions HHS Might Ask During a HIPAA Audit

Some recent projects have touched on HIPAA lately and I thought I’d post on this Computerworld story about hapless Piedmont Hospital. They were the first hospital in to be audited by the Office of the Inspector General at the department of Health and Human Services for compliance with HIPAA security rules (emphasis mine).
The audit was […]


Sensor Productization Challenges and Potential Solutions

Simon Aliwell, Director of the Sensors and Instrumentation Knowledge Transfer Network, National Physical Laboratory, in the UK, has a piece in the latest issue of MDT magazine. His outfit is a network of excellence supported by the UK Technology Strategy Board to develop innovation in sensing. Check out their web site here.
In his story […]


Premier Claims Safety Improvements with Medical Device Unique IDs

Premier Safety Institute sent out the September issue of their (usually) excellent Safety Share newsletter today. Here was the lead item (emphasis in original):
A major move to improve the safety of medical devices - On September 21, Congress approved a law requiring the Food and Drug Administration (FDA) to put into place a unique […]


Devices for Diabetics Improve

Business Week has an interesting story about recent advances in glucose meters and insulin delivery systems for diabetics. Many of the devices in the story aim to improve usability in various ways to improve patient compliance and outcomes. Proper control of blood glucose levels has a tremendous impact on a diabetic's health, quality of life […]


Patent Awarded for Wireless, Batteryless, Implantable Sensors

MEMS vendor Integrated Sensing Systems, Inc. (ISSYS) announced, “that the U.S Patent Office has granted a patent entitled “WirelessMEMS Capacitive Sensor for Physiologic Parameter Measurement” (US Patent No. 6,926,670) which covers the design, manufacturing, and anchoring of miniature, wireless, batteryless, implantable sensors.” (press release - pdf) The summary from the patent:
The invention comprises a […]


MD PnP Update

After the break, Julian Goldman provided a brief update on the MD PnP program.
First, Goldman presented ways integrated systems can support safety, using examples from non-healthcare applications. The classic example from Goldman’s stump speech is the automotive brake/automatic transmission interlock, an almost universal interoperable safety feature.
Safety Inter-locks
From aviation, the airplane landing gear smart alarm […]


AAMI 2007 - Day Two, Afternoon

The IHE PCD crew presented Meeting the Challenges of Integrating the Healthcare Enterprise. Didi Davis from HIMSS, kicked things off describing the IHE organization, what the IHE does, and how they do it. The IHE takes established standards and through collaboration with interested providers and vendors results in a series of “integration profiles” that specify […]


GE Unveils Carescape

GE Carescape is the main focus of a front page story
in Healthcare IT News (dead tree edition that came today). GE
Healthcare brings out the big guns to describe the Carescape solution.
Let's start with the problem as they define it:

Walk – or be wheeled – into any hospital’s emergency or operating room and you’ll likely […]


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