Skip to main content

Advertisement

SpringerLink
Log in

Realizing Digital Signatures for Medical Imaging and Reporting in a PACS Environment

  • Original Paper
  • Published:
Journal of Medical Systems Aims and scope Submit manuscript

Abstract

According to Taiwan’s legislation pertaining to the protection of electronic data, the creators of electronic medical records (EMR) are solely responsible for the security of EMR. However, actual implementations that fulfill the security standards and requirements for electronic medical record systems are still lacking. Most EMR created from picture archive and communication system are not considered secure, as security protection mechanisms have not yet been granted legal status. This paper describes the details of establishing a digital signature system using Taiwan health professional cards. A digital signature system has been included to ensure quality assurance (QA) operations are controlled by technicians, and reporting capabilities have been provided for radiologist. Six imaging modalities and eight types of radiology reports have also been included in the system. Results indicate that the process of creating QA signatures does not have an adverse effect on the workflow of the facility, requiring less time for the signing and verification of radiology reports. This system has already been used routinely online in a real clinical setting for more than 2 years.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

Similar content being viewed by others

References

  1. Yang, C. M., Lin, H. C., Chang, P., and Jian, W. S., Taiwan’s perspective on electronic medical records’ security and privacy protection: Lessons learned from HIPAA. Comput. Methods. Programs Biomed. 82:277–282, 2006.

    Article  Google Scholar 

  2. Health Insurance Portability Accountability Act of 1996 (HIPAA). Available via Centers for Medicare and Medicaid Services. http://www.cms.hhs.gov/hipaageninfo. Accessed 17 Oct 2010

  3. Code NZTHIP (1994) Rule 5: storage and security of health information. http://www.privacy.org.nz/assets/Files/Codes-of-Practice-materials/HIPC-1994-2008-revised-edition.pdf.

  4. Toyoda, K., Standardization and security for the EMR. Int. J. Med. Inform. 48:57–60, 1998.

    Article  Google Scholar 

  5. Digital Imaging and Communications in Medicine (DICOM) Part 15: Security and System Management Profiles. National Electrical Manufacturers Association. ftp://medical.nema.org/medical/dicom/2009/09_15pu.pdf.

  6. Bos, J. J., Digital signatures and the electronic health records: providing legal and security guarantees. Int. J. Biomed. Comput. 42:157–163, 1996.

    Article  Google Scholar 

  7. Ratib, O., Ligier, Y., Bandon, D., and Valentino, D., Update on digital image management and PACS: Web and PACS: Heralding the new age of imaging in the health care community. Abdom. Imaging 25:333–340, 2000.

    Article  Google Scholar 

  8. Lim, E. Y. S., Data security and protection for medical images. In: Feng, D. D. (Ed.), Biomedical information technology, 1st edition. Elsevier, Burlington, pp. 249–257, 2008.

    Chapter  Google Scholar 

  9. Hollerbach, A., Brandner, R., Bess, A., Schmücker, R., and Bergh, B., Electronically signed documents in health care - analysis and assessment of data formats and transformation. Methods. Inf. Med. 44:520–527, 2005.

    Google Scholar 

  10. van der Haak, M., Wolff, A. C., Brandner, R., Drings, P., Wannenmacher, M., and Wetter, T., Data security and protection in cross-institutional electronic patient records. Int. J. Med. Inform. 70:117–130, 2003.

    Article  Google Scholar 

  11. Schüze, B., Kroll, M., Geisbe, T., and Filler, T. J., Patient data security in the DICOM standard. Eur. J. Radiol. 51:286–289, 2004.

    Article  Google Scholar 

  12. Cao, F., Huang, H. K., and Zhou, X. Q., Medical image security in a HIPAA mandated PACS environment. Comput. Med. Imaging. Graph. 27:185–196, 2003.

    Article  Google Scholar 

  13. Brandner, R., van der Haak, M., Hartmann, M., Haux, R., and Schmücker, P., Electronic signature for medical documents - Integration and evaluation of a public key infrastructure in hospitals. Methods. Inf. Med. 41:321–330, 2002.

    Google Scholar 

  14. de Lusignan, S., Chan, T., Theadom, A., and Dhoul, N., The roles of policy and professionalism in the protection of processed clinical data: A literature review. Int. J. Med. Inform. 76:261–268, 2007.

    Article  Google Scholar 

  15. Srivastava, A., Electronic signatures and security issues: An empirical study. Comput. Law. Sec. Rev. 25(5):432–446, 2009.

    Article  Google Scholar 

  16. Kardas, G., and Tunali, E. T., Design and implementation of a smart card based healthcare information system. Comput. Methods. Programs Biomed. 81:66–78, 2006.

    Article  Google Scholar 

  17. Chen, Y. C., Chen, L. K., Tsai, M. D., Chiu, H. C., Chiu, J. S., and Chong, C. F., Fingerprint verification on medical image reporting system. Comput. Methods. Programs Biomed. 89:282–288, 2008.

    Article  Google Scholar 

  18. Wong, S. T., A cryptologic based trust center for medical images. J. Am. Med. Inform. Assoc. 3:410–421, 1996.

    Article  Google Scholar 

  19. Gritzalis, S., Iliadis, J., Gritzalis, D., Spinellis, D., and Katsikas, S., Developing secure web-based medical applications. Med. Inform. Internet Med. 24:75–90, 1999.

    Article  Google Scholar 

  20. Clunie, D. A., DICOM structured reporting. PixelMed, Bangor, 2000.

    Google Scholar 

  21. Riesmeier, J., Eichelberg, M., Kleber, K., Grönemeyer, D. H. W., Oosterwijk, H., and Jensch, P., Authentication, integrity and confidentiality in DICOM structured reporting: Concept and implementation. SPIE Med. Imaging 4685:70–278, 2002.

    Google Scholar 

  22. Lepanto, L., Impact of electronic signature on radiology report turnaround time. J. Digit Imaging 16:306–309, 2003.

    Article  Google Scholar 

  23. Zhou, Z., and Liu, B. J., HIPAA compliant auditing system for medical images. Comput. Med. Imaging. Graph. 29:235–241, 2005.

    Article  Google Scholar 

  24. Liu, B., Zhou, Z., and Huang, H., A HIPAA-compliant architecture for securing clinical images. J. Digit Imaging 19:172–180, 2006.

    Article  Google Scholar 

  25. Kroll, M., Schütze, B., Geisbe, T., Lipinski, H. G., Grönemeyer, D. H. W., and Filler, T. J., Embedded systems for signing medical images using the DICOM standard. Int. Congr. Ser. 1256:849–854, 2003.

    Article  Google Scholar 

  26. Jin P FPGA and ASIC Implementation of ECC Processor for Security on Medical Embedded System. 3rd Information Technology and Applications, International Conference on, 2005. pp 547–551.

  27. Vijay, N. V. K., Sylvanus, A. E., Sergio, C., and Jose, A. R., Security middleware infrastructure for DICOM images in health information systems. J. Digit Imaging 16:356–364, 2003.

    Article  Google Scholar 

  28. Lien, C. Y., Kao, T., Hsiao, C. H., and Keng, C. I., A software-embedded method of security protection applied in indirect imaging in dentistry. J. Med. Biol. Eng. 30:203–207, 2010.

    Article  Google Scholar 

  29. Digital Imaging and Communications in Medicine (DICOM) Supplement 41: Digital Signatures. National Electrical Manufacturers Association. ftp://medical.nema.org/medical/dicom/final/sup41_ft.pdf.

  30. Digital Imaging and Communications in Medicine (DICOM) Supplement 86: Digital Signatures in Structured Reports. National Electrical Manufacturers Association. ftp://medical.nema.org/medical/dicom/final/sup86_ft2.pdf.

  31. Lien, C. Y., Hsiao, C. H., Huang, L. C., and Kao, T., Applying a presentation content manifest for signing clinical documents. J. Digit Imaging 23:152–160, 2010.

    Article  Google Scholar 

  32. Kobayashi, L., Furuie, S., and Barreto, P., Providing integrity and authenticity in DICOM images: A novel approach. IEEE Trans. Inf. Technol. Biomed. 13:582–589, 2009.

    Article  Google Scholar 

  33. Kobayashi, L., and Furuie, S., Proposal for DICOM multiframe medical image integrity and authenticity. J. Digit Imaging 22:71–83, 2008.

    Article  Google Scholar 

  34. Bartel M, Boyer J, Fox B, LaMacchia B, Simon E (2001) XML-Signature Syntax and Processing - W3C Proposed Recommendation. . W3C (World Wide Web Consortium). http://www.w3.org/TR/2001/PRxmldsig-core-20010820/.

  35. Landrock, P., and Pedersen, T., WYSIWYS? – What you see is what you sign? Inf. Secur. Tech. Rep. 3:55–61, 1998.

    Article  Google Scholar 

  36. Ruotsalainen, P., and Manning, B., A notary archive model for secure preservation and distribution of electrically signed patient documents. Int. J. Med. Inform. 76:449–453, 2007.

    Article  Google Scholar 

  37. Lekkas, D., and Gritzalis, D., Long-term verifiability of the electronic healthcare records’ authenticity. Int. J. Med. Inform. 76:442–448, 2007.

    Article  Google Scholar 

  38. Pharow, P., and Blobel, B., Electronic signatures for long-lasting storage purposes in electronic archives. Int. J. Med. Inform. 74:279–287, 2005.

    Article  Google Scholar 

  39. Lekkas, D., and Gritzalis, D., Cumulative notarization for long-term preservation of digital signatures. Comput. Sec. 23(5):413–424, 2004.

    Article  Google Scholar 

  40. Yu, Y. C., Huang, T. Y., and Hou, T. W., Forward secure digital signature for electronic medical records. J. Med. Syst. 36:399–406, 2012.

    Article  Google Scholar 

  41. Huang, K. H., Hsieh, S. H., Chang, Y. J., Lai, F., Hsieh, S. L., and Lee, H. H., Application of portable CDA for secure clinical-document exchange. J. Med. Syst. 34:531–539, 2010.

    Article  Google Scholar 

  42. Digital Imaging and Communications in Medicine (DICOM) Supplement 95: Audit Trail Messages. National Electrical Manufacturers Association. ftp://medical.nema.org/medical/dicom/final/sup95_ft.pdf

  43. Morgan, M. B., Branstetter, B. F., Lionetti, D. M., Richardson, J. S., and Chang, P. J., The radiology digital dashboard: Effects on report turnaround time. J. Digit Imaging 21:50–58, 2008.

    Article  Google Scholar 

Download references

Acknowledgments

The authors would like to acknowledge the technical support and data collecting provided by Mr. Wen-Jen Hsieh, Mr. Wei-Chung Chen and Mr. Yao-Yi Chen. This work was supported by the Department of Health and the National Science Council of Taiwan under Grant NSC 97-2114-E-010-002 and NSC 101-2917-I-564-060.

Conflict of interest

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

  1. OFFIS – Institute for Information Technology, Escherweg 2, Oldenburg, 26121, Germany

    Chung-Yueh Lien

  2. Department of Teleradiology and Radiology, Kaohsiung Veterans General Hospital, Kaohsiung, 813, Taiwan

    Tsung-Lung Yang

  3. Department of Medical Informatics, Tzu Chi University, Hualien, 701, Taiwan

    Chia-Hung Hsiao

  4. Department of Biomedical Engineering, Hungkuang University, Taichung, 433, Taiwan

    Tsair Kao

  5. Department of Biomedical Engineering, Hungkuang University, 34 Chung-Chie Rd, Shalu, Taichung, 433, Taiwan

    Tsair Kao

Authors
  1. Chung-Yueh Lien
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Tsung-Lung Yang
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Chia-Hung Hsiao
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Tsair Kao
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Tsair Kao.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Lien, CY., Yang, TL., Hsiao, CH. et al. Realizing Digital Signatures for Medical Imaging and Reporting in a PACS Environment. J Med Syst 37, 9924 (2013). https://doi.org/10.1007/s10916-012-9924-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s10916-012-9924-1

Keywords

Search

Navigation