Think Global, Act Local – Lessons Learned in a Global Compliance Experience Kathy Lundberg Chief Compliance Officer Boston Scientific.

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Presentation transcript:

Think Global, Act Local – Lessons Learned in a Global Compliance Experience Kathy Lundberg Chief Compliance Officer Boston Scientific

Global Code of Business Conduct

3 Respect for People – Open Communication is Key Translate materials into the local language  translated the Code into 13 different languages  toll free phone numbers for the Helpline for every major country

4 Respect for People – Open Communication is Key  Translation of “complaint” in a complaint handling training

5

6 Respect for People – Open Communication is Key  How you present information; can also have different cultural reactions

7 Respect for People – Open Communication is Key  Power of live conversations and personal relationships  Boston Scientific met with people locally or traveled to their location Live summit meetings Monthly phone calls  These live connections opened doors for Boston Scientific in terms of finding out what the local issues were, and allowed us to connect people or raise awareness of different compliance issues

8 Legal/Compliance Obligations Keep current on changing requirements  Participation in GHTF  International legal team and compliance teams are watching for new or evolving requirements and standards  Local “eyes and ears” are the compliance/quality connections within the geography

9 Legal/Compliance Obligations Separate International Customer Relationship Policy to meet the global needs

10 Legal/Compliance Obligations  BSC provides procedures and a Toolkit customized to local requirements to ensure compliance with local laws and regulations

11 Sample Toolkit

12 Legal/Compliance Obligations Sometimes conflicting expectations  Different regulators have different expectations for notification of key events SEC FDA International government authorities

13

14 Legal/Compliance Obligations  Transparency in one geography may be perceived differently in another  SEC requirements  Product Performance Report information – may be viewed differently

15 Legal/Compliance Obligations Respect all local laws and regulations…not just the medical device approval requirements For example: Privacy Radio Frequency Environmental Health and Safety

16 EU Privacy 1.Key Privacy Differences Between US and EU 2.Data governance Medical device approvals are pan-European, however, privacy, security and post-market requirements are established by each country

17 Country Specific Regulations Each country may have additional data protection regulations which need to be followed Italy Spain Germany Austria France Netherlands UK (Requirements confirmed via external legal opinion) Additional controls applied to data depend on the structure of the data controller relationship Some countries require additional controls to any data that originate in that country (e.g. Italy) Other countries deem the data controller country rules to apply

18 Latitude EU Privacy – What’s Required Policies and Procedures Contractual Clauses De-identification Data Use Sensitive Data Encryption Patient And Customer Consents Privacy Officer Website Privacy Policy Data Controller

19 A Side by Side Comparison US- HIPAAEU - 95/46/EC Protected Health Information (PHI)- identifiable health information – 18 items. PHI Can be written, electronic or oral. Data DefinitionsPersonal Data – any information relating to an identifiable natural person (referred to as the data subject)

20 Je ne suis pas encore rangé des voitures I am not giving up my wild lifestyle yet. (literally: I am not yet parked away from the cars) IEEE Security and Privacy Magazine