1. Software as a Device The application of the EU-Medical Device Directive and the US-Medical Device Data Systems regulation to a private hospitals software catalog.

6. Point of Change - US FDA Centre for Devices and Radiological Health made the clear statement ; “ Under the Federal Food and Drug Cosmetic Act, Healthcare Information Technology software is a medical device” 25 th February 2010 Dr. Jeffery Shuran Director

7. Point of Change - EU In May 2010 the UK agency Medical and Health related Regulatory Agency (MHRA) reviewed all incidents where were reported and concludes as software related issues. Table 1: Percentage of reported incidents reported as software issues.

11. Medical Devices Directive 93/42/EEC (EU-MDD) “ medical device’ means any instrument, apparatus, appliance, software , material or other article, whether used alone or in combination , including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose

13. Application: EU-MDD Decision diagram. (COCIR, 2010)

14. Application: EU-MDD Audit Decision Matrix

15. Application: US-MDDS Decision diagram for qualification of software (HIMSS Analytics, 2010)

16. Application : US-MDDS Audit Decision Matrix

17. Software Catalogue

18. Results Summary

21. Results US-MDDS

22. Harmonised Standards