1. The document analyzes how software would be classified under the EU Medical Device Directive and the US Medical Device Data Systems regulation by applying them to a private hospital's software catalog. 2. There are significant differences in how software would be classified under each regulation. The EU regulation considers more software to be medical devices than the US regulation. 3. If bespoke healthcare IT is developed, the hospital could be considered a medical device manufacturer under the EU regulation but not necessarily under the US regulation. 4. Further research is needed on how complementary standards and guidelines could apply, how software evaluation and vendor selection may differ between public and private institutions, and how regulations apply to software in general practitioner offices.

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.

2. Introduction Frank Maxwell Project Manager, Professional Services EMEA, Acquia

3. Relevant Experience 14 years Professional Services Delivery (Enterprise Software) Industries: Pharmaceutical Clinical Applications (R&D) Healthcare Solutions US: Harvard Risk Management Foundation, Brigham and Women’s Hospital, Children’s Hospital, Florida Hospitals Network HSE NHS

4. Research Focus “ How can software be classified as a medical device?” US-MDDS- Medical Device Data Systems (MDDS) 21 CFR 880.6310 EU -MDD – Medical Devices Directive 93/42/EEC (MDD) with amendment M5 (2007/47/EC)

5. Research Focus To apply the two regulations against the software catalogue in use by private European hospital. Will the outcome be different for each regulation? Where bespoke HIT development is involved, does HIT classification position a hospital as a medical device manufacturer? If the outcome is different for each regulation are there any indications as to why? What further research could be developed on the findings?

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.

8. USFDA - Medical Device Data Systems (MDDS) 21 CFR 880.6310 15 th February 2011: The new rule was announced 18 th April 2011: MDDS rule became effective 16 th May 2011: All medical device manufacturers must be registered and list their medical devices All manufacturers must implement a FDA compliant Quality System within 12 months of registering. 18 th April 2012: A medical device reporting system for devices must be implemented by manufacturers for their listed devices.

9. USFDA - Medical Device Data Systems (MDDS) 21 CFR 880.6310 The electronic transfer of medical device data The electronic storage of medical device data The electronic conversion of medical device data from one format to another format in accordance with a preset specification The electronic display of medical device data

10. Medical Devices Directive 93/42/EEC (EU-MDD) 2005: EU Commission introduced amendment M5 2007/47/EC May 2010 : EU Commission brought the rule into force

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

12. Medical Devices Directive 93/42/EEC (EU-MDD) Diagnosis, prevention, monitoring, treatment or alleviation of disease Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap Investigation, replacement or modification of the anatomy or of a physiological process Control of conception

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

19. Results Summary Will the outcome be different for each regulation? Significant Yes – Where is the harmonisation that was intended Where bespoke HIT development is involved, does HIT classification position a hospital as a medical device manufacturer? Yes

20. Results Summary What further research could be developed on the findings? The evaluation of complementary regulation, standards and guidelines? GAMP ? The implications to software evaluation and selection? Comparison across vendors of similar products? Private versus public institutions? What about the software found at GPs

21. Results US-MDDS

22. Harmonised Standards

23. Thank you Email: [email_address] frank.maxwell@gmail.com Linkedin: http://ie.linkedin.com/in/frankmaxwell