Connectivity and Hackability
It is somewhat ironic that Hospira and Cerner announced a new collaboration on Hospira’s infusion...
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Author: William Hyman
Some Funky Cybersecurity Math
Assessing the magnitude and significance of cyber threats has at least two important purposes. One...
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The FDA October Workshop on Cybersecurity
If it were possible to be unaware of the general problem of cybersecurity, the recent Sony hack...
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DHHS OIG Work Plan Targets Networked Devices
The Office of the Inspector General (OIG) of the U.S Department of Health and Human Services has...
Read MoreA Medical Device Recall of an EHR-like Product
The recent recall (links below) for McKesson’s Anesthesia Care system raises interesting questions about potential information system failure modes as well as what system/software functions cross the imaginary line between...
Read MoreLegislation Seeks to Deregulate Medical Software
Introduced in the House back in October was the wittily named Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 which has the acronym SOFTWARE. Not to be outdone on the creation of legislative...
Read MoreHave You Read a Disclaimer Lately?
Some time ago Tim Gee pointed out that a major vendor for an in hospital communication system included the following statement in its documentation: "This product is not intended for use with patient monitoring devices or other...
Read MoreMedical Mobile App Draft Guidance Reaches 2nd Birthday
On July 21, 2011 the FDA released its "Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Application." We have discussed this draft and mobile apps generally here, here, and here. As with all...
Read MoreFDA Offers (draft) Guidance on Cyber Security
The FDA has issued a draft guidance document on the expected content of premarket submissions with respect to medical device cybersecurity. This guidance targets individual medical devices rather than the network they may be...
Read MoreValuing Private Certification
There are currently several private entities that seek to certify medical apps, connectivity solutions, EHR record exchange, and other products, services and people in our sphere of interest. Given the ongoing proliferation of...
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