This article debates the impact regulation has on innovation.
My 2 cents: Regulation provides consumer protection; standards provide access to data, which often leads to innovation.
More thoughts and notes…
- Mobile “apps” seem to always be cited as examples of innovation, but I believe the Web services (based on REST) that enable mobile and Web access are the key to innovation—the client will change over time (browser, smartphone, downloaded app, HTML5 app, tablet, etc.), but a secure, flexible and reliable API makes the change less painful. Thankfully, standards bodies (DICOM, HL7) are focusing efforts in this area. The Web services and the clients don’t need to be from the same vendor, or even use the same technology—that is the beauty of REST.
- I like how people that issue regulations make statements about the benefits of these rules, such as driving innovation (they claim). Shouldn’t we ask the people that have to operate (and attempt to innovate) within the interpretation of these guidelines? I intentionally used the word “interpretation”, as different regulatory professionals seem to have different opinions on what burden of process needs to be met for medical devices.
- The FDA’s eagerly-anticipated guidance on mobile apps and devices “should be out by October.”