1. No category

Nordic Market Access
Brian Hedegaard
Senior Consultant @ DELTA
Continua Open House, Orange Labs, Paris 2015-24-06
Healthcare in Denmark
•
CPR number - Unique identifiers on each
individual
•
Used across all systems
•
All data is digitalised
•
Health data is accessible by:
•
Health and care professionals
(dedicated systems)
•
Citizen (Sundhed.dk and dedicated
systems)
•
Coherent treatment
•
Shared care on medicine
•
High focus on telemedicine / e-Health
•
Multi vendor strategy on procurement
•
5.5 billion € investment in new hospitals
•
20% for ICT and Medical devices
Hospital
Municipality
Private companies
General
Practitioner (GP)
Other
Patients
Financial flow in healthcare
Tax
State
Block grants
(0,12)
Municipalitiy
Nursing home
(5,2)
Block grants (81%)
Co-finansing (18 %)
Home care
Activity based
Finansing(1%)
Region
(15,1)
Total: 20,42 Billion € (~ 3620 € per capita)
2013 figures in billion €
Hospital
source: www.sum.dk
General Practitioner (GP)
The Market place
Device availability vs.market demand
- The Hen and Egg problem !
3 tenders having Continua as compititive parameter
Total number of devices available (Continua certified
and CE marked)is too low
Implementation is progressing
- More solutions in production
- More solutions moving from project to scale
Closing the gap…
”Percieved” obstacles
•
•
•
•
•
•
Regulatory compliance
Price tags of devices
Lack of knowledge about infrastructure and
requirements
Continua Certification
Usability
Insight to daily operations for health organisations
Not
• Infrastructure - http://bit.ly/1zDkaEh
Supportive innitiatives
Telemed.nu
The project 'Denmark as a pioneer country in telemedicine' (2013 – 2015)
is Funded by The Danish Agency for Science, Technology and Innovation.
www.telemed.nu
http://4s-online.dk/english.php
CoLab Denmark
The concept
”CoLab Denmark represents a conceptual model
for the development of medical- and assisted
living technologies cross-sectoral within the
Danish Healthcare system.
A CoLab is a localized testbed, anchored directly
into daily operations. The real experts – the
operating staff at the hospital and municipality –
all pool their knowledge, needs and facilities into
a common model for collaboration drawing in
citizens and companies.
CoLab Plug & Play
A reliable test
”You can test and trial your
solution with Plug & Play
in connection with how your
solution operates - both
technically, organisationally
and in relation to the citizen”
We provide access to:
• Unique testing facilities (Collaborative
network)
• Tailored development processes
• Service and advice
• User Panel consisting of experts and citizens
• Certification of your technology according to
international standards (Collaborative network)
CoLab Denmark
Think large!
International standards as a mean to growth!
Closing notes
Infrastructure is in place
Infrastructure tools available- for free
Tools, test facilities and knowledge exists
4 Nordic countries set on making
interoperability happen
Procurers are ready
Products needed
Thank you for your attention!
LLL
LLV
LLO
”Through five localized CoLabs and CoLab Plug & Play we will through crosssectoral collaborational partnerships support he development, testing and
implementation of assisted living technologies taking in a user-oriented
approach with their actual needs as an off-set”
CoLab Denmark are…
LLS
P&P
R&R
CoLab Denmarks vision is to…
Strengthen the distribution of assisted
living technologies cross-sectoral between
the Region of Southern Denmark, the
municipalities, general practices and private
businesses
Develop a mutual model cross-sectoral for
designing, testing and implementation of
assisted living technologies through close to
real life environments
CoLab Denmark value
proposition for…
Hospitals and municipalities by
granting a solid basis for decisionmaking to invest in next-gen assisted
living technologies
Specialists in developing patient/citizen
centered assisted living technologies
through evidence-based, cross-sectoral
collaboration partnerships between
public-private organizations
The citizen via active-involvement and
enhancing user experience when
developing products - opting the
citizens quality of life
Private companies, who get an easier
and ”coordinated” access to testing
their products in an close to real life
setting, and in turn shortens time-tomarket cost
Brian Hedegaard
[email protected]
http://com.colab-denmark.dk/
Nordic Market Access
Sweden
Johan Lidén
Swedish Medtech Association
(chairing the ICT group)
[email protected]
Overview of Sweden health system
• Sweden is a Public HealthCare system, 9.7M patients
• 20 county councils and 290 municipalities in 5
regions,
– 9 regional hospitals in 7 university hospitals.
– 1000 primary care units (vårdcentraler)
• Key information,
–
–
–
–
–
9M inhabitants,
HealthCare is paid through taxes (97%)
One personal identifier (personnummer)
99.9 % digitized Health Information.
5 key EMR system vendors.
Homecare key actors and Influencers
• Municipalities (primary buyers)
– Kommunförbunden
– MFD
• HealthCare (HeathCare regions)
–
–
–
–
–
–
SKL,
Inera,
eHälsomyndigheten,
The larger regions, Stockholm LL, Västra Götaland, Skåne
Vinnova
Etc.
• Companies (major players in the field):
–
–
–
–
CGI
Tieto
Telia Sonera
Etc.
Strategy for Personal Connected
Health and TeleCare
 During 2014 SALAR worked with a strategy for Personal
Connected Health and TeleCare.
 Continua framework gives the possibility to start up in
a small scale and thereafter grow
 A framework for Personal Connected Health will be a part
of the National Reference Architecture during 2015
 The recommendation is to establish a organisation in
Sweden with collaboration with the Nordic Countries
 Ongoing pilot projects will be evaluated during 2015
Relevant for strategy selction for personal health
– There is a shift right now from analog (POTS) to digital (IPbased) phone networks that drives the re-investment for PERS
(municipal)
– Municipalities have already invested in Social care systems
Enabling/supporting infrastructures
•
•
•
•
•
•
•
•
•
•
Inera (T-boken)
HIP (SLL)
SIS
Vinnova
Läkemedelsverket
SICS
Swedish ICT
Tillväxtverket
Almega
Värmland Continua testbed
Relevant technical and regulatory frameworks
•
•
•
•
•
•
T-boken (Inera)
MDD
PUL
PDL
SITHS
HSA
Continua
Personal Device
Aggregation
Manager
Health
Records
Telehealth
Service
Center
Thermometer
Pulse Oximeter
CCD
Pulse /
Blood Pressure
PCD 01
Weight Scale
Glucose Meter
Continua BT
Profiles
Cardio / Strength
EHR
Independent
Living Activity
HIE
PHR
Peak Flow
Medication
Adherence
Physical Activity
Device
Connectivity
Wide
Area
Network
(WAN)
Interface
Health
Record
Network
Interface
9
NHIN
Agenda del I – Inspiration
09.30
Kaffe
10.00
Information och diskussion om pågående
arbete med sourcingstrategi och Ineras
framtida tjänsteutbud
Johan Assarsson, VD Inera
Sara Meunier, Arkitekt och Utredare Inera.
Ca 11.00 Bensträckare.
Lunch - blir av någon lättrörlig typ i flygande fläng
12.00
3R, Innovation och
Daniel Forslund, Innovationslandstingsråd, SLL
Agenda II – Slutna Delen
• Mötet öppnas
• Riktlinjer för Swedish Medtech’s möten
• Stockholm Digital Care
• Uppföljning av dagens presentationer
Jan H
Johan L
– Inera - Johan Assarsson & Sara Meunier
– SLL - Daniel Forslund
• Rapporter och information från Swedish MedTech.
– Det som har varit och det som skall komma
Jan H
• Samrådsgrupper. Vilka finns och vilka vill vi skall finnas Jan H
• Rapporter från möten, samarbeten och pågående projekt
– Nationella samrådsgruppen
Mötet skjutet till den 27 Maj
– Vitalis, Rapport från programrådet
Fredrik L
– Utredningar och projekt
Johan L
Utredningar och Projekt
• SLL ”Egenutveckling av NPÖ2” finansierat av SLL, Vinnova och
Inera(?).
• Ineras upphandlingar
– Skadeståndskrav för säkerhetstjänsten och tjänsteplattformen.
– Erbjudande av konsult-tjänster till Landstingen.
• Konkurrensverkets behandling av driften av Nationella
tjänsteplattformen.
• Arbetsgrupp "MTU i nät“ (SLL).
Agenda III – Medlemsföretagens aktiviteter
• Möten och konferenser
–
–
–
–
HIMSS
Vitalis
WoHIT
Almedalen
•
Chicago
Göteborg
Riga
Visby
Intersystems, CGI, Intel, Cambio, EVRY
– VGR´s Hemsjukvårds-dag
– HOSIT
•
•
•
•
12-16 April
22-24 April
11-13 Maj
28 Juni – 05 Juli
Hösten 2015
xx Okt
Upphandlingar
Hur vi marknadsför oss som bransch.
IHE/Continua, information om dagsläget.
Medlemsrekrytering
Jan H
Johan L
IHE/Continua – tidplan
•
•
•
•
•
•
•
Inriktningsbeslut enligt ovan i januari 2015.
Kompletterande utredningar januari – april 2015.
Beslut om etablering av organisation i april 2015.
Ansökan om medlemskap i IHE och Continua i april 2015
Beslut om IHE och Continua som rekommenderade standardramverk för
implementationer i april 2015.
Från januari 2018 skall för svenska förhållanden godkända IHE och
Continua profiler användas vid alla upphandlingar av kommuner och
landsting där tillämpligt.
Under perioden fram till januari 2018 ställs inte obligatoriskt krav på att
produkter som upphandlas skall vara IHE/Continua-kompatibla dock är det
en stark rekommendation. Leverantörerna skall dokumentera kompatibilitet
genom ett självdeklarationsförfarande eller genom att redovisa resultat från
tester vid anvisade testcenter.
IHE/Continua
•
Organisationens - förslag på namn: Servicecenter - arbete finansieras av SKL med
en successiv övergång till medlemsfinansierad verksamhet.
•
Medel tillskjuts för det förta året för att täcka en initiering av arbete med omfattning
enligt nedan:
Etablering av Servicecenter för att säkra införande, användning och utveckling av
standarder. Centret ska arbeta med aktiv spridning av information samt rådgivning
om IHE och Continua. Centret ska även arbeta aktivt i processer internt i de båda
organisationerna.
•
•
Utredningsresurser t.ex. för att ta fram en svensk ”Referensarkitektur för
interoperabilitet med IHE och Continua”. I detta ligger att klargöra behov av teknisk
plattform i hemmet som kan hantera tjänster för vård och omsorg.
•
Resurser för fördjupad nordisk samverkan. Etablering av samarbete kring test och
certifiering.
Agenda V - Avslutning
• Kommande ICT-dagar 2015 (10-16)
• Tisdag 15 september
• Torsdag 26 november
–
Programrådsmöten för 2015 är Tisdag 18 Augusti och Tisdag 3 November. (9-12)
• Övriga ärenden
• Mötet avslutas
• Nu övergår vi till att diskutera Överprövningsutredningens rapport
Kathrine Myhre, CEO Oslo Medtech, – June 24th 2015 at Continua Open House
Continua and Nordic Market access –
Standardization as a tool for innovation and
growth?
Overview
• Short introduction to Oslo Medtech and the
Norwegian NCE health technology cluster
• Standardization as a tool to reach global
markets – what is important
• Other important factors as;
• access to test facilities
• use of innovative procurement
processes
Key figures - Oslo Medtech
• Founded November 2009
• Cluster, organized as a
nonprofit membership
organization
• 175 members/partners
• The full health value chain
represented
• 37 bill NOK/4,2 bill e turnover
and 5,7 % growth in value
creation in 2013
• Partner of Norwegian
Innovative Clusters as a
Norwegian Centre of Expertise
Vision, mission & main goal
Vision
Oslo Medtech is to become one of the
most innovative global health
technology clusters within 2020.
Mission
Our mission is to develop and
industrialize world class health
technology products and services that
enables sustainable and high quality
treatment and care, and Norwegian
Medtech industry growth.
Main goal
To increase the competitiveness
of the companies in the cluster
and strengthen the attraction of
the cluster internationally.
Stimulate and facilitate for innovation and growth
• Facilitate cooperation between R&D,
companies and hospitals/local
authorities
• Stimulate and facilitate market driven
innovation projects and procurement
processes
• Facilitate clinical trials and testing
• Enhance the knowledge and access to
global markets, accelerate companies
growth
• Attract development and investment
capital
• Co-housing in Medtech Growth House
Ecosystem
Innovation & global growth
Innovation
plattforms
Incubator/
StartupLab
TTO
Medtech Growth House (coworking space)
Testfasilities/Living lab
EU program
Investor network
Pre-seed fund
Competence
program
International
networks
Meeting places
175 Cluster partners
From market need to industry growth
Demographic changes
The increase in chronic diseases
Need for efficiency and quality in
diagnostics and treatment
Need for health care
administration efficiency and
quality
R&D and
regulatory
competence
Business
model & other
metodology
Hospitals &
testfacilities
Capital and
Market
access
Fitness and Wellness
Future models for care giving
World Wide Growing
Markets
Develop world class health
technology solutions
Industry growth and
value creation
Norwegian potential and competitive advantage
Strong R&D,
technology and
knowledge base
Well-estblished
health system and
test facilities
Strong cluster with
trustful relations
Early adapters
Standardization
a tool for
Innovation and
growth?
1: Future oriented & attractive standards
The standards need to
follow the technology
development, drivers
and trends …. Stay
“modern” …
The needs and voice
of the users are
strong; they want to
live independent lives
Catalyzing Technology to Support Family Caregiving
11
2: Focus the standardization on a «high» level …
Make standards for the
cause of safety and quality of
life for the patients – and for
innovation, competition and
industry growth … (Do not
make standards for the
cause of the standard…)
3: «Jungle» of standards – OBS OBS
Continua is one, but not the only
standard that governments and
companies needs to understand
and adopt to ….
«Heavy» Medtech regulations
(ISO 13485 etc)
Non-invasive measurement of glucose
Be aware – don’t make a too big
burden on the industry that kills
innovation ….. Stay coordinated ..
4: Need for testfacilities
Companies need access to
testfacilities to test and verify
their products and solutions
Providers need testfacilities to
test and verify infrastructire and
products and solutions that they
want to procure …
Nordic+ collaborating testfacilities
Name testbed
Nationality
Intervention Centre, Oslo University Hospital
Norway - Oslo
Sunnaas testfacility, Sunnaas hospital
Norway - Oslo
C3 – Living Lab
Norway - Oslo
Karolinska University hospital
Sweden - Stockholm
Nordic Medtest
Sweden - Karlstad
SLL Innovation
Sweden - Lund
Sahlgrenska Science park
Sweden
Helsinki University Hospital
Finland - Helsinki
Innovation Centre Island
Island - Reykjavik
NHS network of testbeds
England - London
Norwegian eHealth testfacility
Norway - Grimstad
CoLab
Denmark
Nordic mHealth
Partners:
• Oslo Medtech (No)
• Sahlgrenska Science Park (SW)
• Cobis (DK)
• Delta (DK)
• Lund Life Science (SW)
• Oulu Bisiness (FI)
• Teknopol/Mobile Heights (SW)
Project coordinator
Objective of the project:
Create fast growing mHealth
companies that reach the global
market.
Focus:
• Business development
• Network of experts and expertize –
regulatory expertize
Innovative procurement
Innovative procurement with the objective of procuring
what is needed, stimulate innovation & make clear division
of roles between procurers and developers/industry
Phase 2 – Pre-commercial procurement
Phase 1 – Need & challenge assessment, planning & anchoring
Phase 3 – Innovative procurement
Partners in the PPI Net consortium:
Denmark:
Finland:
Sweden:
Norway:
Follow us on
@OsloMedtech
OsloMedtech
Contact
www.oslomedtech.no
[email protected]
19
19
PERSONAL CONNECTED HEALTH AND CARE
IN NORWAY
CONTINUA SUMMIT PARIS 24TH OF JUNE 2015
THOR STEFFENSEN, NORWEGIAN DIRECTORATE OF HEALTH
NORWEGIAN HEALTH AND CARE ORGANIZATION
National Health Authorities
• Ministry of health and Care Services
• Directorate of Health
Responsible for regulation, financing at national level, national services and
registries, infrastructure, standards, architecture
Specialist care
Primary care
Private care
• 4 regional health
authorities
• 428 municipalities
• 4100 GPs
• 5 % of health
care
Responsible for local EMR and communication systems, and adherence to national
strategies and standards
Vendors (8 EMR vendors, several specialist systems vendors)
Responsible for systems development and conformance to standards
One patient – one record



Health professionals: Easy and secure
access to patient information
Citizens and patients: Access to user
friendly and secure digital services
Access to data for quality
improvement, health monitoring,
management and research.
WE WILL USE PERSONAL CONNECTED HEALTH AND CARE TO ACHIEVE….
…better lives for the patients
• Almost everyone want to get the
confidence to stay at home –
as long as possible
• Everyone wants to cope with life as long as possible
…more efficient health care
• Use health personnel where
needed most
• Access to the right information
when needed
NORWEGIAN FOCUS 2014-2020
Enable people to manage their own
life and health longer
• National initiative to use new
telecare services in the municipality
health care
• National large scale project using
new telehealth services for people
with chronic diseases
• National project using mHealth for
reducing development of noncommunicable diseases (part of the
WHO/ITU program Be He@lthy Be
Mobile)
WHY STANDARDIZATION?
National
health autorities
Municipalities/
primary care
• Easier to perform service
innovation accross health care
units with common ICT framework
• Common ICT framework gives
larger market with predictable
requirements for the suppliers
(no more unique products for each
customer)
Innovation
Hospitals/
Specialists
Industry
• Open ICT interfaces make it
possible for suppliers to deliver
only a part of the total solution.
That will open the market for
smaller, innovative, suppliers.
WHY CONTINUA?
• The only international initiative to establish and end-to-end ICT framework
for personal connected health and care with open standards.
• The Norwegian ICT framework for personal connected health and care will
be based on the Continua framework.
Continua is dedicated to the development of its Design Guidelines that include
global industry standards to ensure end-to-end, plug-and-play interoperability of
personal connected health devices for the seamless and secure collection, transmission
and storage of personal health data.
NORWEGIAN ICT ARCHITECTURE
FOR PERSONAL CONNECTED HEALTH AND CARE
Personal area
Service center
Public solutions for access and
exchange of health information
ON TOP PRIORITIES IN NORWAY AT THE MOMENT
• Use cases within social care
• Pilots within remote treatment of people with chronical deseases
Private
National health sector
Alarm devices with
voice response
Assisting tools
(tablets, pill
dispenser, nightly
digital supervision
e-key etc.)
Location and
tracking devices
Medical
monitoring devices
Responsecenter
application
Personal
HUB
Internet
Open,
standardized
protocols
Central
HUB
Health
information
exchange
WORK PLANS FOR THE NORWEGIAN ICT FRAMEWORK FOR PERSONAL
CONNECTED HEALTH AND CARE
1. Recommended national ICT framework for personal connected health
and care ready by end of 2015
2. Piloting the framework during 2016
3. Implementing national components of the framework during 2017
4. National information center for purchasers and suppliers regarding the
national ICT framework - up and running during the autumn 2015
5. Nordic cooperation
6. Active participation in international standardization and Contuinua work
NORDIC STATUS
Country
Official statement
Status
Finland
Recommend Continua – but not
decided as mandatory
Own solution for HIS (Kanta) – not based on
XDS. National PHR as service interface for
information from personal devices.
Recommend Continua for communication
with PHR.
Sweden
Recommend Continua – but not
decided as mandatory
Own solution for HIS (Open Exchange
Infrastructure) – not based on XDS. National
PHR with APIs for registration of
information. Recommend Continua for
communication with PHR.
Denmark
Recommend Continua – but not
decided as mandatory
Decided an e-health reference architecture
based on Continua. Has implemented XDS –
but that is not in use yet.
Norway
Decided by the Government to be
used as a framework for PCH&C
Working with defining a referance
architecture for PCH&C based on Continua.
Planned implemented during 2016/2017.
Today, Continua do not cover all needs.
NORWEGIAN/NORDIC WISHLIST TO CONTINUA
A
Device
B
Personal
HUB
Central
HUB
Proactive market adoption
On B interface:
• Alarm handling with multimedia communication over IP
• Location and tracking possibilities (indoor and outdoor)
• Service activation (turn on/off monitoring, e-keys etc.)
• Modernization of WAN (HL7 FHIR….)
On A interface:
• Modernization of TAN/PAN (include other protocols)