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Re: [scrumdevelopment] FDA approval for software systems

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  • Jeff Sutherland
    Charlie, The functionality in software systems and its relevance to diagnosis and treatment affects FDA approval. Radiology systems tend to require it,
    Message 1 of 1 , Dec 6, 2003

      The functionality in software systems and its relevance to diagnosis and treatment affects FDA approval. Radiology systems tend to require it, although must other clinical systems do not, even though diagnosis and treatment is directly affected. The threat is always there that the FDA will suddenly require approval for the typical electronic medical record.

      However, EMRs are so underutilized in the industry as it is (helping to make patient safety the 3rd leading cause of death) there would be a lot of political pressure to keep the FDA from adding more requirements for deployment.

      I believe that one day we will have a federal requirement that hospitals and physicians will not be allowed to treat patients without adequate clinical systems that are used to guide and monitor treatment. Just as airlines cannot fly without the FAA. It's just too risky.

      At that point, the approval process would become so basic to the development process that it would probably just need to be a standard piece of the Scrum backlog. We would want to make it as agile as possible.

      The future, in my view is model driven development and this would automatically generate required documentation (as well as most of the code). Agile techniques could be easily be deployed here, as the first Scrum at Easel Corporation was a totally model driven development environment.

      It is interesting that Software Development magazine reported recently that their readership is the top 30% of developers and that 20% of these use UML tools. Probably only about 6% of total developers use UML tools or other model driven environments which is about the same percentage of healthcare institutions that use medical records to drive physician orders (the largest component of medical error).


      Message: 1
      � Date: Thu, 4 Dec 2003 19:37:34 -0500
      � From: "Charlie Trainor" <charlie.trainor@...>
      Subject: RE: Heavy weight requirements


      ISO 9000 is usually something a company can choose to follow
      or not (although there may be considerable pressure from clients),
      but if you want to sell a radiology system in the US, isn't FDA
      approval a necessity?
      Just curious.

      - Charlie

      > -----Original Message-----
      > From: Jeff Sutherland [mailto:jeff.sutherland@...]
      > Sent: December 4, 2003 11:07 AM
      > To: scrumdevelopment@yahoogroups.com
      > Subject: Re: [scrumdevelopment] Heavy weight requirements
      > When I had over 500 developers at IDX, the standard I laid
      > down for agile development which worked was:
      > 1. No heavy weight requirement would affect a Scrum directly
      > 2. FDA approval, CRM, ISO, anything that layered more
      > documentation would be wrapped around the SCRUM and cost
      > justified as a separate project for purpose of meeting standards.
      > This gave the CFO a real choice. He could see exactly what
      > the cost was of extra work for the heavyweight process. He
      > decided against ISO and for FDA approval for radiology systems.
      > No Scrum was affected.
      > Jeff Sutherland
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