Summary
Objectives:
Our objectives were to analyze and assess data formats for their suitability for
conclusive and secure long-term archiving and to develop a concept for legally secure
transformation of electronically signed documents that are not available in data formats
appropriate for long-term archiving.
Methods:
On the basis of literature review and Internet searches we developed general evaluation
criteria to assess data formats with regard to their suitability for conclusive and
secure long-term archiving. The assessment of data formats refers to format specifications
and available literature. For the analyses of the transformation of signed documents
we analyzed legal requirements on the basis of laws and ordinances as well as technical
requirements by means of literature reviews, Internet searches and technical specifications.
Results:
The following evaluation criteria are suited for this kind of assessment of data
formats: transparency and standardization, stability, presentation and secuity According
to our assessment the following data formats are most suitable for conclusive and
secure long-term archiving: PDF for formatted and unstructured text documents, XML
for markup languages, TIFF for images in general, DICOM for medical images and S/MIME
for the storage of e-mail. To transform electronically signed documents we propose
an elementary procedure and universal basic model in form of an XML schema definition
that includes the necessary legal and technical information.
Conclusions:
If electronic documents are to replace paper-based documents in patient records,
they have to conform to the criteria for secure long-term archiving. The analyzed
data formats are to be extended by mechanisms to guarantee the long-term security
of electronic signatures. To transform large quantities of documents in a legally
secure way, our basic model has to be extended for automated procedures.
Keywords
Computerized patient records - data security - documentation/standards - electronic
signature - transformation
