45th Civil Aviation Medicine Forum

1. 45th Civil Aviation Medicine Forum 6th March 2018, Aviation House, Gatwick

2. 1 Welcome and Introductions 2 Apologies

3. 3 Approval of Agenda

4. 4 Approval of Minutes of Last Meeting • Amendments and corrections • Approval

5. 5 Matters arising and actions not covered in subsequent agenda items • Fatigue – availability and willingness of AMEs to support data gathering relayed to Head Flt Ops 22/1/18 • Removal of limitations by AMEs – await new Medical IT system • Automated response set up • CAA Ref No in subject will become essential: new method of transmission of information using Huddle being introduced. • GDPR information for AMEs

6. 6 Medical Department Structure-update

7. 7 Medical IT System Replacement Project • Project on track for ‘Go Live’ by end March 2019 latest • ‘Off-the-shelf’ solution requiring configuration but minimal bespoke development • Web-based solution, Cloud based data storage, access via CAA portal • Single applicant record – AMEs will see the same system as users at the CAA • GDPR compliant • Penultimate stage of supplier selection – 3 potential suppliers currently being evaluated • Decision on successful bid due mid-April • Subsequent work to include data migration, configuration, UAT and training

8. Records Management (AOB) • Electronic transmission of large files • Naming protocols for documents

9. EASA and Regulatory Activities

10. 8 Regulatory Activities / Information • EASA Standardisation • Audit Findings • EASA Rulemaking • Update of Part MED • Drugs and alcohol testing • Peer support programmes • EAMR • Age research • UK Exemption for Self Declaration

11. EASA Standardisation • UK CAA Participation in EASA Audits of other States • 2017 • TJ Switzerland • SE Denmark (cancelled) • 2018 • EH Netherlands • SM Greece • Full (Aircrew and ATCO) EASA MEST Inspection Audit July 2017

12. UK MEST Audit Findings & Actions (1)

13. UK MEST Audit Findings & Actions (2)

14. PART MED Changes • PART MED • Drugs and alcohol testing at initial Class 1 • Comprehensive mental health assessment • Mental Health Section will be amalgamation of Psychology and Psychiatry • General • Tidying up of AME responsibilities around non-disclosure • Suspension and Revocation of certificates • Restructuring of text to remove general catch-all statements • Other: Thoracic aneurysms after surgery, CAD test • EAMR has been included in the Part MED changes

15. PART OPS Changes • PART OPS • Pilot support programme (National P-PAN) • Psychological ‘assessment’ pre-line training • Random drugs and alcohol testing

16. EAMR key points – Why?European Aero-Medical Repository Recommended by Germanwings Taskforce: National Authorities to collaborate and exchange information Pilots increasingly mobile- system designed to eliminate medical tourism Reduces reliance on pilot self-declaration and reduce the risk of non availability of past medical history and assist with growing workload of medical certification. Makes some key information available online even if current systems are paper based.

17. EAMR key points – What? Web based system - Class 1 pilots only Currently 14 fields to be populated (6 basic fields, 8 medical certificate fields) Each information change will be notified direct to the pilot by email (helps data integrity) Responsibility for the creation of initial record, and subsequently data entry, maintenance and quality lies with each NAA and its AMEs. NAA and their AMEs will require access (currently gratis) and will require training (training material will be provided but delivery is NAA responsibility) Unclear what the rate of data refresh at outset will be, target is real time. European data protection issues have been taken into account by EASA

18. EAMR key points – When? Entry into force with update of PART MED expected ‘mid 2018’ EASA expect full data capture to be complete in 12- 15 months. As each pilot is revalidated or recertified, then the initial record is created (UK - 25,500 records 12 month cycle) Data capture will not involve historic data in Phase 1; no assurances on historic data given for phase 2 NAA engagement with the database likely to be audited (UK MEST Autumn 2018) Interface with individual NAA IT systems not planned until phase 2 (requirements not yet written so timescales unknown)

19. EAMR – Risks and issues for CAA and AMEs Resource impact to set up systems Increased AME and MCT/medical SSC workload challenge Running two databases side by side (MARS, EAMR) presents a data integrity risk Diverse (European) AME community with vastly differing IT skills represents a real risk to compliance and data integrity Phase 2 feeds from NAA systems likely to cause significant problems Will need to be designed into oversight system and will require resource to monitor and oversee

20. EU Regulations and EASA Rulemaking • NPA 2017-22 Update of Parts ARA.MED and ORA.MED • RMT .0424 Regular update of Part MED • RMT .0707 Merging Parts MED and ATCO MED • EASA Age 60 Research Project • Vienna Age 60 Meeting

21. GA Medical Self-Declaration

25. GA Medical Self-declaration • Proposal by GA industry / stakeholders to extend self-declaration for Pilots flying EASA aircraft after 8th April 2018

26. Brief from Head of Medical Assessment

30. Class 1 and 3 Casework Part MED and Part ATCO.MED have implementing rules that permit AMEs to make fit/unfit assessments and indicate which cases should be referred to the authority. Already happening in other member states Adjustments to MARS/AME On Line Workshops in August/September 2017 for AMEs -> e-Learning Platform training course AMEs now able to make fit/unfit assessments on Class 1 and 3 cases following periods of unfitness and record these on MARS

31. Initial Class 1 OML Issue around initial issue of a Class 1 medical certificate with OML. IR currently states that OML can only be added to medical certificate of existing CPL/ATPL/MPL holder. Recent case in media about initial applicant with HIV infection; current IRs/AMCs do not permit unrestricted certification with HIV. CAA has submitted an Article 14(4) exemption to notify the EC of the issue of initial Class 1 medical certificates with OML whilst encouraging EASA to commission research to consider initial Class 1 with OML rule change. CAA working with HIV specialists to consider mitigations for unrestricted certification

32. Insulin Treated Diabetes Mellitus

33. Guidance Material • Various documents requiring revision, partially revised, awaiting publication on website. • Recent activity: • Process document for producing and publishing guidance material • Collation of all material, stage of completion, authors etc • Central repository for developing material on CAA Sharepoint site

34. Brief From Head of Oversight and Training

35. Oversight • Team comprising Head of Oversight and Training, 3 auditors and 2 aeromedical support officers • Oversight of 4 AeMCs, 188 Active AMEs (129 UK Class 1, 29 UK Class 2, 30 overseas Class 1). • 5 AMEs currently suspended (2.5%) • Approaching end of first 3 year audit cycle • 90 site audits in 2017 (on target to meet EASA requirement) • Findings and observations at most audits (2-3 average)

36. Training • Extensive internal and external training to meet EU requirements • Support to AMEs (online training launched along with Class 1 and 3 casework seminars) • Delivery of lectures to national and international audiences • StR in Aviation and Space Medicine • Basic and Advanced Aviation medicine course contributions • Diploma in Aviation Medicine (teaching and examination support)

37. Brief From Head Aero medical Safety Systems and Emerging Technologies

38. Head of Aeromedical Safety Systems and Emerging Technologies Overall Purpose • To act as the lead for Medical on aeromedical safety systems, compliance and risk management. • To provide expert advice on new technologies and innovations in Aviation and Space Medicine to the CAA and external stakeholders. • To systematise and oversee departmental research activities. • Other projects and pop-ups

39. Aeromedical Safety Systems, Compliance and Risk Management. • Set up Medical Safety Risk Panel • Systematise Safety Risk Data collection and reporting • Horizon Scanning • ‘Pop-ups’ • Balloon CAT review • GA medical self-declaration proposals

40. CAA regulatory SMS Medical

41. For medical… • Accident data (CAT and GA) • AAIB • THREAT and AAG • Other sources • Mandatory Occurrence Report Data • Aircrew (and ATCOs) • Other, RPAS(?), commercial balloons, FISO, RFFS, spaceplanes Identify key risk areas and develop safety risk proformas where necessary • Oversight data • AME audits • AeMC audits • Case series/ by condition(s)

42. Medical Capability Team Research • Aim… Better coordination, visibility and reporting of work in progress • Data sources • developing more user-friendly MARS searches • S23 & data access • (Age project) • Discussion of new projects especially for trainees/students/interns etc • Systems • Statistical analysis • Ethics • Reporting & governance • Publications and Presentations

43. Safety Concerns and Issues from Members

44. Forthcoming Aviation and Space Medicine Events

45. Aviation & Space Medicine Meetings AAME Leicester 17 March 2018 ASMA Dallas 7-11 May 2018 RAeS Spring lecture 24 May 2018 (provisional) ECAM Prague 20-23 September 2018 AMDA Aviation Health Conference 25-26 September 2018 ICASM Bangkok 11-15 November 2018

46. Any Other Business Items

47. Dates of Next Meetings Thursday 13 September 2018 at 1400 hrs, Aviation House Thursday 28 February 2019 at 1400 hrs, Aviation House