One of the areas of expertise that we’ve developed over the years on behalf of our medical industry clients is HIPAA compliance testing. This testing supports new requirements from the FDA governing any medical facilities that keep client records in data form, or that move client information and research over networks. Any such activities have to be shown to conform with HIPAA guidelines because by law, client records have to be kept secure. Failure to obtain official validation can result in a government shutdown of operations.
HIPAA compliance testing can be a huge headache if you don’t have specially trained and knowledgeable people doing it. For example, all of the computers in a network have to use matching guidelines and be identically set up in order to obtain FDA validation. You cannot go outside the guidelines, even if there are several newer service packs for software than those that are approved.
Whenever Fehl-Safe Solutions does computer, software or network installations and upgrades for doctors’ offices, biotech companies, or medical research firms and support vendors, we know that you have to get the work approved by the FDA before it is initiated. And we know how to help you cut through 400-page guideline manuals to get those approvals.