"mHealth: Should we regulate?" Presentation by Antoni Dedeu, Director of the Catalan Agency for Health Evaluation (AQUAS) at Catalonia Government

1. mHealth: Should we regulate?
Toni Dedeu, Director of the Agency for Health Quality and Assessment of Catalonia
(AQuAS)
23rd February 2016

2. The importance of mHealth

3. mHealth Assessment Model
1. Is it needed?
2. Which solutions should/may be evaluated?
3. Who are the potential target users?
4. Which domains, sub-domains and evaluation
perspectives should be considered in the Model?
5. Which is the best process to follow?
6. Regulation / certification is a “need”? A “must”?

4. Which model?
It could be used for evaluation of the broad range of
existing mHealth solutions and innovations.
Evaluate apps as a PRODUCT at a certain point of
time (evaluation is needed for each new version)
Evaluate the SERVICE where the app is only one of
the elements
The same one can be evaluated as a PRODUCT and as
part of a SERVICE with different conclusions.

5. mHealth Assessment Model
1. Is it needed?
2. Which solutions should/may be evaluated?
3. Who are the potential target users?
4. Which domains, sub-domains and evaluation
perspectives should be considered in the Model?
5. Which is the best process to follow?
6. Regulation / certification is a “need”? A “must”?

6. Healthcare
satakeholders
End-users
Industry
Macro
•Public authorities
•Policy makers
•…
Meso
•Hospital Managers
•Health insurances
•Academia
•…
Micro
•H Prof
•Patients
•Citizens
•Developers
•…
Target users

7. Advantages for all involved stakeholders
Reliable & comparable information
Estimation of real impact
Trust in quality & safety
Sustainability of the business model
ASSESSMENT
Evidence generation
REGULATION
END USERS
Informed choices
PROVIDERS / POLICY MAKERS
Service re-design and scale-up
DEVELOPERS / INDUSTRY
Technology improvements

8. mHealth Assessment Model
1. Is it needed?
2. Which solutions should/may be evaluated?
3. Who are the potential target users?
4. Which domains, sub-domains and evaluation
perspectives should be considered in the Model?
5. Which is the best process to follow?
6. Regulation / certification is a “need”? A “must”?

9. Various initiatives have been launched to support prescription of
apps at the point-of-care, but offer only partial assessment
There is an extensive
knowledge and
capacity which could
be used to support a
comprehensive
evaluation
Established research methodologies (quantitative and qualitative)
Conceptual models, frameworks and guidelines developed for design and evaluation of
eHealth interventions
MAST, GEP-HI, STARE-HI, HOT-fit, AHRQ Eval toolkit, …
HTA and other evaluation agencies and similar organizations

10. • Users
• Organization
• Health & Social care
system
• Community
• Users
• Organization
• Health & Social care
system
• Community
Evaluation Domains - Proposal
•Users
•Organization
•Health & Social
care system
•Community
•Users
•Organization
•Health & Social
care system
•Community
Technical
maturity
Risks
Benefits
Resources
needed
mHealth
Solution

11. 1. Is it needed?
2. Which solutions should/may be evaluated?
3. Who are the potential target users?
4. Which domains, sub-domains and evaluation
perspectives should be considered in the Model?
5. Which is the best process to follow?
6. Regulation / certification is a “need”? A “must”?
mHealth Assessment Model

12. Process to follow
Tailoring of the evaluation
• Aspects to be assessed may be selected according to the
purpose of the evaluation (intended use / intended impact)
and would vary depending on the type of the mHealth solution
• Evaluation methods applied are specific for each assessed
aspect (sub-domains), including quantitative and qualitative
methodologies
Further definition of relevant tools that should be used in each sub-domain
is needed

13. Evaluation as a continuous process

14. mHealth Assessment Model
1. Is it needed?
2. Which solutions should/may be evaluated?
3. Who are the potential target users?
4. Which domains, sub-domains and evaluation
perspectives should be considered in the Model?
5. Which is the best process to follow?
6. Regulation / certification is a “need”? A “must”?

15. Guidance for Industry and FDA staff on Mobile Medical Applications
(FDA, Feb 2015)
Three categories of mobile apps are defined:
a) REGULATED mobile medical apps (the ones which comply with the definition of medical device)
b) Mobile apps subject to ENFORCEMENT DISCRETION (may meet the definition of medical device, but
pose a lower risk to the public)
c) UNREGULATED mobile apps (do not meet the definition of medical device)
The majority of available mobile apps on the market currently fall in the unregulated groups b) and c).
There are six subcategories within ENFORCEMENT DISCRETION :
Patient self-management
Patient trackers
Access to contextually relevant information
Patient communication and telemedicine
Simple, professional calculators
Connectors to EHRs
Current regulatory framework - US

16. • No integrated health regulation framework with a single regulatory body for
medical devices, such as FDA in the US.
• The EU regulates mHealth in a number of ways:
by means of medical devices regulation
regulation of personal health data
reimbursement of healthcare rules
product liability
• To be legally introduced in the EU market, a medical device should bear the
Conformite Europeenne (CE) mark.
• mHealth as a service is not regulated, but the software to provide the
service is under the e-Commerce directive (SaaS: Software as a Service).
Current regulatory framework - EU