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Standards & Regulatory

Updated Standards Aim to Encrypt Wired Networks

Applying this level of security to medical devices will be problematic.


IEEE Completes 802.11r Fast Wi-Fi Roaming Standard

This new standard establishes security and QoS connections for the client radio at the new access point, before it roams between the two, so the transition can take place in less than 50ms.



IEC 80001 to Impact Providers

This is an ongoing requirement, and not a one time shot.


What’s Wrong with the Proposed FDA MDDS Rule

It is foreseeable… that an MDDS could initiate a command to a medical device that results in unintended operation of the device.


IEC 80001 - An Introduction

The intent of this standard is the application of risk management to enterprise networks incorporating medical devices.


Riegel v. Medtronic

Good news to medical device makers, and bad news to patients who want to sue them.


FDA Issues New MDDS Rule

Besides the obvious question of whether the FDA is really serious about regulating MDDS, a few things jump out as areas that need clarification.


IHE PCD Connectathon - Is Your Vendor There?

The IHE North America kicked off their Connectathon yesterday. This is the second year (?) that the Patient Care Device domain (PCD) has had something to show in the Interoperability Showcase at HIMSS.
I chatted with Todd Cooper via Skype and received the following update:
As background, there are approximately 390 engineers from 70 companies and 2 […]


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 […]


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