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FDA Issues Final Guidance on Wireless Medical Devices 27 Aug 2013 | 05:26 am
On August 14, 2013, AAMI reports that the FDA has, “issued a new guidance document on integrating RF technology into medical devices.” The draft version of this guidance on RF wireless medical device...
Review: EHR, A Systems Analysis of the Medications Domain 3 Aug 2013 | 12:23 am
A while back I was provided with a review copy of the book, Electronic Health Record: A Systems Analysis of the Medication Domain, by Alexander Scarlat, MD. This book is intended to serve as a practic...
Medical Mobile App Draft Guidance Reaches 2nd Birthday 16 Jul 2013 | 02:42 am
On July 21, 2011 the FDA released its “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Application.”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, he...
FDA Offers (draft) Guidance on Cyber Security 14 Jun 2013 | 09:57 pm
The FDA has issued a draft guidance document on the expected content of premarket submissions with respect to medical device cybersecurity.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 tha...
HIT Vendor Seeking MDDS for Meaningful Relationship 25 May 2013 | 09:17 pm
As noted before, from time to time I answer questions and exchange ideas with folks from hospitals, companies and with students. It’s a karma thing with me – if I can help out with reasonable effort i...
Clinical Workflow & Technology Integration Summit 20 May 2013 | 10:33 am
On June 7th, 2013 the Texas Children’s Hospital and Smith Seckman Reid are producing an educational workshop on medical device connectivity. Nursing is the predominate perspective explored in this eve...
Enterprise-Wide Medical Deivice Integration and CIS Workflow 14 May 2013 | 08:26 am
Last month I spoke at the first CIS Qatar International Conference in Doha Qatar. My topic was the Importance of Enterprise Wide Medical Device Integration in CIS workflow. You can download a copy of ...
Alarm Fatigue Plagues Hospitals. Again. Still. 8 May 2013 | 10:21 pm
On April 8, 2013, the Joint Commission published a Sentinel Event Alert on medical device alarm safety in hospitals. Once again, alarm hazards tops the ECRI Institute’s 2013 Top 10 Health Technology H...
Valuing Private Certification 9 Apr 2013 | 08:57 pm
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 th...
How Big a Loophole is “Wellness”? 18 Mar 2013 | 07:40 pm
The medical app and regulatory pot is being stirred as products continue to appear, including those with questionable FDA credentials, or lack of credentials. As discussed in our earlier posts on apps...
