The Great Thing About Standards
There’s an old saying that the great thing about standards is that there are so many to choose from. This is clearly evident in the Health Care IT arena. The standards landscape is getting a little crowded, despite the fact that the push to actually integrate and support these standards seems to take a back seat to refining and creating more and more of them. Right now, I’m dealing with several of these standards at once – SAFE, XAdES and CDISC ODM to be specific. And, this is just a tiny fraction of the health care IT standards collection – there are more than 200 entries on the so-called “short list” of standards that apply to electronic records in the industry.
As standards go, the SAFE specification is relatively simple, as it is mainly a set of guidelines for how signatures must be created and validated as opposed to a format specification. The XAdES standard, in contrast, is a more formal XML-based digital signature specification that can provide timestamping and embedded revocation information. A few forms of XAdES signatures may
be made SAFE compliant, but the SAFE specification does not entirely overlap the XAdES standard; not all XAdES signature forms are SAFE compliant.
XAdES, specifically XAdES-X-L and XAdES-A, seems well suited for use in various CDISC [Clinical Data Interchange Standards Consortium] standards, including the Operational Data Modeling standard. The ODM standard provides an XML schema for maintaining clinical trial results.
I don’t really have a problem with the proliferation of standards in the health care IT space so long as these standards aren’t redundant, and in this particular case they aren’t. However, the more standards that are devised, the more expensive it’s going to become for applications to be compliant, especially when there are standards that are tangentially related, and then more standards have to be created to formally correlate them.