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Introduction to the Medical IT, Medical software and Health Informatics forum
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Introduction to the Medical IT, Medical software and Health Informatics forum
Introduction to the Medical IT, Medical software and Health Informatics forum
Introduction to the Medical IT, Medical software and Health Informatics forum
Introduction to the Medical IT, Medical software and Health Informatics forum
Introduction to the Medical IT, Medical software and Health Informatics forum
Introduction to the Medical IT, Medical software and Health Informatics forum
Introduction to the Medical IT, Medical software and Health Informatics forum
Introduction to the Medical IT, Medical software and Health Informatics forum
Introduction to the Medical IT, Medical software and Health Informatics forum
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Introduction to the Medical IT, Medical software and Health Informatics forum


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health informatics, medical it (information technology), medical software
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  Post Number #1  
Old 6th March 2012, 07:46 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,088
I Say... Introduction to the Medical IT, Medical software and Health Informatics forum

Hello all

Welcome to the new forum under "medical" here on the Cove. The idea of this forum is to have a place, here in the Cove, to discuss subjects which are hot today and will be even hotter in the following years - the fields of medical information technology, medical software, health IT, and whichever name you might have heard (I could list another 2 or 6 different ones I've heard on the last few years). Although each term I cited can be linked to all or some parts of thius field, the main idea is the interaction of IT/software with healthcare.

There are a lot of activities in this field, and some of those (and which I myself am more involved into) are:

- the standardization works of ISO TC 215 - Health Informatics

- standards for medical device software and health software created by IEC 62 A / ISO TC 215 JWG 7 and IEC 62 A / ISO TC 210 groups

- a series of standards (80001 series) dealing with risk management of IT networks incorporating medical devices, created by IEC 62 A / ISO TC 215 JWG 7

- the works of a lot of institutions/associations/etc. such as HL7, IMIA, IEEE EMBS 11073, and a lot more.

This does not mean that the forum is only related to works of standardization on this area.

One importnt aspect right now is, differently from, for example, the medical device field, the medical IT/health informatics field is not that regulated (and the regulations nowadays are somewhat scattered) - and a lot of things are really blurring at the moment. However, due to the increasing concern with the subject, regulators are becoming aware of the possible need of regulatory enforcement actions (iphone health apps, anyone?). This forum will also come in handy, anticipating and providing ground for discussion of future regulations on the field.

So, please feel free to begin threads on related topics and ask the questions which, in fact, every one of us might have right now!
Thank You to Marcelo Antunes for your informative Post and/or Attachment!

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  Post Number #2  
Old 9th March 2012, 05:34 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,195
Re: Introduction to the Medical IT, Medical software and Health Informatics forum

A Quick Bump!

Comments? Feedback?

Thank you very much!!

Stijloor.
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  Post Number #3  
Old 5th June 2012, 09:33 AM
drpaige

 
 
Total Posts: 1
Re: Introduction to the Medical IT, Medical software and Health Informatics forum

I am new to the Medical Device compliance arena.....I have been immersed in HIPAA/HITECH for many years. I am working with a company who is designing a variety of devices and software. I see many new programs available in the market. Is there a place to see if they have filed to check for SE?
Many thanks......
  Post Number #4  
Old 5th June 2012, 06:14 PM
Ronen E

 
 
Total Posts: 3,379
Re: Introduction to the Medical IT, Medical software and Health Informatics forum

Quote:
In Reply to Parent Post by drpaige View Post

I am new to the Medical Device compliance arena.....I have been immersed in HIPAA/HITECH for many years. I am working with a company who is designing a variety of devices and software. I see many new programs available in the market. Is there a place to see if they have filed to check for SE?
Many thanks......
Hello and welcome to the cove

By SE, you mean Substantial Equivalence (510k)?

If so, you could chech the FDA's 510k database:

http://www.accessdata.fda.gov/script.../cfPMN/pmn.cfm

This will return finalised submissions. I'm not aware of a submissions-in-progress DB that is publicly open, but the gap would typically be under 3-6 months.

Cheers,
Ronen.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #5  
Old 25th July 2017, 06:32 PM
gauravmnm

 
 
Total Posts: 1
Re: Introduction to the Medical IT, Medical software and Health Informatics forum

Hi,
The patient Engagement is also one of the growing area in Healthcare-IT.
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