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Creating the digital glue between life science and healthcare

Maiken Hedegaard M.Sc. Pharmacy, IT Consultant

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Digital glue needed: Life Science - Healthcare

Agenda

Guidance: When creating digital glue between life science and healthcare…

Walkthrough of digital gaps between life science and healthcare

A life science case story – Implementing a new electronic format XEVPRM

A healthcare case story – Mobility strategy for the capital region of Denmark

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Healthcare Case: Making a healthcare mobility strategy

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• Client: Capitol Region of Denmark

• 40.000 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 2012-2017

• Budget: As cheap as possible

Client pains

Regional IT strategies A quick win– Mobility PoC

Bring Your Own Device (BYOD) vs. Corporate Owned

Device (COD)

iOS mobile device + email/calendar

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Approach

•infrastructure, resources, legislations, security (MDM), hygiene standards DATA COLLECTION:

•security, administration, clinical, it INTERVIEW OF STAKEHOLDERS

•end-users and stakeholders to identify needs INNOVATION WORKSHOP

•a weighted prioritising of areas TRENDING OF DATA

•mobility strategy roadmap of 2012-2017

•a final recommendation of a mobility PoC REPORT WRITING

•iPhone 5, COD, MDM Afaria

•PoC: Adverse drug reaction app, E2B (R3) -> e-journal system

CHOICES MADE

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Mistakes and key learning points

Regional IT strategies A quick win– Mobility PoC

Bring Your Own Device (BYOD) vs. Corporate Owned

Device (COD)

iOS mobile device + email/calendar

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Mobility strategy was too dependent on

unfinished IT-strategies

PoC Died: No IT-support, different LS

and HC medical vocabularies for E2B

integration

Corporate Owned Device (COD) with

MDM Afaria

Huge gaps in network, 3G, cable, Wi-Fi?

Life Science Case: XEVPRM – A new EMA submission format

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• 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

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

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Approach

•Setting the validation/quality bar

•Full vs. pragmatic validation of the XEVPRM solution

IT VALIDATION

•Retrieval of MAH agreements, medicinal product categories such as dosage form, ATC codes, administration route, etc. DATA COLLECTION

•Various XEVPRM IT-solutions were used in the life science industry

•Some uploaded directly to EudraVigilance, but still required a local copy

TESTING

•Excel sheet data collection approach

•A full GxP V-model validation of the XEVPRM IT-system

CHOICES MADE

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Mistakes and key learning points

Tight deadline: July 2011 – July 2012

New IT-system or direct upload to EMA

website?

EV controlled vocabularies: Data

collection and clean-up of all MAH medicinal products

Urgent need of resources: IT and LoB

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Testing first - SOP and validation

documentation last

New IT system should not have been chosen

Data collection should have been started

earlier

Scope should have been aligned with

resource capacity - IT and LoB

When creating digital glue – make a strategy

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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

Existing electronic formats – a good starting point

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In life science

• 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

In healthcare

• 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)

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Digital glue needed in Life Science - Healthcare

XEVPRM

MedDRA E2B

HL7

SNOMED CT

LOINC

DICOM

GS1/Data Matrix

eCTD

HL7

3D Printing – Why not print a heart?

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Children's National Medical Center Washington DC

E-textiles- Wear your heart on a sleeve?

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UK Centre for Defence Enterprise

Smart Jacket - Neonatal ECG Industrial Design, Eindhoven, NL University of Technology

Bionics – Prosthesis or super limbs?

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Hugh Herr - Director of the Biomechatronics Group at the MIT Media Lab

FDA: 2011 - 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

Legislations – A constant step behind in LS HC

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The digital glue in LS HC is…

the end-user

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

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..if you do not feel like this…

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…you have not tried hard enough with new technology!