Electronically signed documents in health care--analysis and assessment of data formats and transformation.

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 security. 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.

[Past, present and future of optical cards for medical use].

In the hospital, the chart is an important medical information record. However, it is not easy to refer to chart records. Although a computer is useful in referring to the chart, the most critical defect is the lack of exchangeability between hospitals. An optical card is a new medium for medical use. It has a large capacity for electronic storage, low price and high security. Therefore, the author considers this card a second medical chart. As another card, there is the IC card, which has some limitations in medical use. Although both systems are being examined experimentally, there is no actual practice in the medical field. The reason for this lack of wide use, it is thought that these systems are not yet supported by national health insurance.

[Development of perinatal management system using optical card and regional health information network].

In Kagawa Prefecture, a perinatal management system using the optical medical card and the information network has been introduced since October 1998. Four hospitals(Kagawa Medical University, Sakaide Municipal Hospital, Uchinomi Town Hospital and Tsuda Prefectural Hospital) are connected with each other through the health information network(Kagawa Health and Welfare Information Network) organized by Kagawa Prefecture. (http://www.hw.kagawa-swc.or.jp/net/) Patients' clinical data are described on the optical card based on the "standard format of the Japan Association of Obstetricians and Gynecologists(JAOG). (http://www.jaog.or.jp/JAPANESE/MEMBERS/JOUHOU/H10/index.htm). Clinical information including the fetal heart rate(FHR) and sonography (JPG) can be easily transmitted through this network(on line). Without the network, patient data can also be transmitted using the optical card(off line). There are still many technical and social problems to be solved in the future, research into the use of medical information network should be continued.

[On standardization of optical memory cards].

An optical card optimizes recording of medical data since it has a large memory capacity, data cannot be interpolated by the addition method, and data are protected from disruption by magnetic force or static electricity. Now that international standards have been established for the card, reader/writer control, and data management, a highly-compatible optical card system for medical use can be fabricated. The optical card is expected to play an important role in the social system as a promising medium for recording or exchanging individual health data, which is anticipated to grow in the near future.

IS & C system and file protection mechanism.

This paper reports a new extension of IS & C (Image Save And Carry) project. Because IS & C is an off-line system and requires full compatibility so as to enable medical data interchange with ease among hospitals and clinics, specifications that are indispensable for compatibility have been standardized by the IS & C committee. The IS & C system is supposed to be used in medicine, so the file protection mechanism for the security of the recorded files has been also developed. The characteristics of IS & C volume and file structure and the second national project being carried out in National Cancer Center Hospital are briefly explained as well.

Comparative imaging technologies in the cardiac catheterization laboratory.

Evaluation of digital technology in the cardiac cath lab has introduced a desire to extend these technologies into electronic storage capability. Cine film is the current standard for image archiving because it meets the most important requirements of superior resolution, long-term stability, universal viewing and single-patient unit record capabilities. The major limitations of film include serial viewing (versus random access) and its incompatibility with computer techniques, such as quantitative angiography. Manufacturers and vendors have introduced several archiving alternatives that address the limitations of film. These options currently require trade offs and/or compromises in image quality, longevity, cost and numerous other requirements. Investments in alternatives should be made after comprehensive review of the expected productivity gains, anticipated media, equipment and supporting service cost improvements and prospective technological enhancements. This article has introduced a number of the issues that should be considered in comparing archiving media. As technology evolves and standards are developed, this task will become easier. In the meantime, no system to date has been able to achieve the existing advantages of film while overcoming its limitations.

Converting to an optical disk system.

Optical disk technology is a move to the future. It is an exciting time to brave the new frontiers and change from a manual to an optical disk system. Since the technology is so new in health care environments and because each facility is unique, there is no "right" way to do optical imaging. Opportunities flourish to "do it your way." The process is challenging and time consuming, but the rewards of providing health information users with a quality record system make the investment worthwhile. Complete, thorough planning and education will ease the transition to tomorrow's system. Stop dreaming, make a commitment, and move forward--optical disk systems in health care are achievable successes!

Practical use of optical cards in medical care.

This paper reports excellent results with respect to application of optical cards in medical care, based on improvements in the technology for encoding optical cards and devices used to increase read-write speed, and also reports the issuance of the first Japanese standards for the data format of optical cards.