Creating the digital glue
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1 Creating the digital glue between life science and healthcare Maiken Hedegaard M.Sc. Pharmacy, IT Consultant 1
2 2 Digital glue needed: Life Science - Healthcare
3 Agenda A healthcare case story Mobility strategy for the capital region of Denmark A life science case story Implementing a new electronic format XEVPRM Walkthrough of digital gaps between life science and healthcare Guidance: When creating digital glue between life science and healthcare 3
4 Healthcare Case: Making a healthcare mobility strategy Client: Capitol Region of Denmark employees (80 % Clinical/20 % admin staff) 30 municipalities 8 different e-journal systems 5 main hospitals + several minor hospital units Scope and execution: Mobility Strategy for employees in the period of Budget: As cheap as possible 4
5 Client pains Regional IT strategies A quick win Mobility PoC Bring Your Own Device (BYOD) vs. Corporate Owned Device (COD) ios mobile device + /calendar 5
6 Approach DATA COLLECTION: infrastructure, resources, legislations, security (MDM), hygiene standards INTERVIEW OF STAKEHOLDERS security, administration, clinical, it INNOVATION WORKSHOP end-users and stakeholders to identify needs TRENDING OF DATA a weighted prioritising of areas REPORT WRITING mobility strategy roadmap of a final recommendation of a mobility PoC CHOICES MADE iphone 5, COD, MDM Afaria PoC: Adverse drug reaction app, E2B (R3) -> e-journal system 6
7 Mistakes and key learning points Mobility strategy was too dependent on Regional IT strategies unfinished ITstrategies PoC Died: No ITsupport, different LS A quick win and HC medical Mobility PoC vocabularies for E2B integration Bring Your Own Corporate Owned Device (BYOD) vs. Device (COD) with Corporate Owned MDM Afaria Device (COD) Huge ios gaps mobile in network, device + 3G, /calendar cable, Wi-Fi? 7
8 Life Science Case: XEVPRM A new EMA submission format Clients: Life science companies in Europe XEVPRM = extended EudraVigilance Product Report Message To harmonise medicinal product terminologies in EU Regulatory Affairs and Pharmacovigilance Enacted by July 2011, compliance deadline: 02-JUL-2012 XEVMPD Database = XEVPRM file database with controlled vocabularies of medicinal product data 8
9 Client Pains Tight deadline: July 2011 July 2012 New IT-system or direct upload to EV website? EV controlled vocabularies: Data collection and clean-up of all MAH medicinal products Urgent need of resources: IT and LoB 9
10 Approach IT VALIDATION Setting the validation/quality bar Full vs. pragmatic validation of the XEVPRM solution DATA COLLECTION Retrieval of MAH agreements, medicinal product categories such as dosage form, ATC codes, administration route, etc. TESTING Various XEVPRM IT-solutions were used in the life science industry Some uploaded directly to EudraVigilance, but still required a local copy CHOICES MADE Excel sheet data collection approach A full GxP V-model validation of the XEVPRM IT-system 10
11 Mistakes and key learning points Testing first - SOP and Tight deadline: July validation 2011 July 2012 documentation last New IT-system or New IT system should direct upload to EMA not have been chosen website? EV controlled Data vocabularies: collection should Data have collection been started and clean-up earlier of all MAH medicinal products Scope should have been Urgent aligned need with of resources: capacity IT and LoB - IT and LoB 11
12 When creating digital glue make a strategy Find a problem that mobility/new tech can solve Focus on end-users Test your product end-user & technological requirements Comply with electronic formats, quality + security guidelines Map network, support, back-end architecture, resources Don t get seduced by the device 12
13 Existing electronic formats a good starting point In life science In healthcare Regulatory Affairs: XEVPRM format, ectd, eclinical Data Interchange Standards Consortium (CDISC) Pharmacovigilance: XEVPRM, E2B (R2-R3), HL7, MedDRA Supply chain: Serialisation/Serialization GS1, Data Matrix, EAN ISO/TC 215 HL7 DICOM (Digital Imaging and Communications in Medicine) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) Clinical Care Classification (CCC) System Logical Observation Identifiers Names and Codes (LOINC) 13
14 Digital glue needed in Life Science - Healthcare XEVPRM GS1/Data Matrix HL7 DICOM LOINC ectd HL7 E2B MedDRA SNOMED CT 14
15 3D Printing Why not print a heart? Children's National Medical Center Washington DC 15
16 E-textiles- Wear your heart on a sleeve? Smart Jacket - Neonatal ECG Industrial Design, Eindhoven, NL University of Technology UK Centre for Defence Enterprise 16
17 Bionics Prosthesis or super limbs? Hugh Herr - Director of the Biomechatronics Group at the MIT Media Lab 17
18 Legislations A constant step behind in LS HC FDA: Draft Guidance for the Industry and Food and Drug Administration Staff Mobile Medical Applications HIPAA: Omnibus Rule - Privacy, Security, Breach Notification and Enforcement final rules EMA: ICH Guidelines on electronic formats (E2B, HL7, ectd, XEVPRM, etc.) ISPE: GAMP5 Guideline for GxP IT validation EU: New Data Protection Directive 95/46/EC 18
19 The digital glue in LS HC is the end-user 19
20 Take home message - when creating digital glue Focus on end-users Expect no basic platform It takes time It is expensive Respect security aspects It is rewarding and fun 20
21 ..if you do not feel like this you have not tried hard enough with new technology! 21
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