RE: Regulatory requirements for images

We are developing pathology educational imaging software for realtime interactive online visualization of huge (20,000 to 100,000 pixels per side) path images, and have done a fair bit of research on this - but beware, nothing definitive has surfaced...

As far as we can tell, pathology is 'right under the radar' for imaging regulation. As far as medical imaging is concerned, pathology simply does not appear to exist. Pathologists have not extensively adopted digital imaging yet, and there appear to be no standards for image formats, acceptable quality, or storage systems in place yet. DICOM, for example, has no pathology imaging modalities, although DICOM 3.0 has/had (?) a ballot under consideration for a 'Pathology Visible Light Image' supplement. Seems not to go far enough.

We are in the process of building a specialized pathology archiving and retrieval system for large path images, and as far as we know, most other solutions are 'home-brewed' from commercial non-pathology solutions, since regulation is not in place.