TechnologyForumDigitalHealthStåhlberg071015

Finnish opportunities in
digital health technology
and regulatory restrictions
7.10.2015
Director, Regulatory Affairs and
compliance
Tom Ståhlberg
FiHTA
Finnish digital health technology
Terveysteknologia Suomessa – syntymästä kuolemaan
Entäs softa?
Copywright Tom Ståhlberg
Finnish opportunities in
digital health technology
and regulatory restrictions
When is a software a medical
device?
What is the implication?
Can we live up to the demands?
Mobile apps as an example
Safety, safety, safety…
Copywright Tom Ståhlberg
Medical device or not?
Medical device specific laws in about 100 countries
What about the other (about) 300 countries? Wild West?
Pharmaceutical law (MD = “drug” or quasi-drug)
Custom-related laws and product liability laws
Copywright Tom Ståhlberg
European Union Medical Device Directives
Active Implantable Medical Devices, AIMD (90/385/EC)
Medical Devices, MDD (93/42/EC)
In Vitro Diagnostic Medical Devices, IVD (98/79/EC
Software included from the beginning!
The amended Medical Device Directive, MDD 2007/47/EC
transposed to the Finnish
Suomen Laki Terveydenhuollon laitteista ja tarvikkeista (629/2010)
Software stronger emphasis!
Intended Use
”Intended by” the manufacturer is the key to
if it is a medical device or not!
Copyright Tom Ståhlberg
Lääkinnällinen laite (Medical device): määritelmä
Instrumentti, laitteisto, väline, materiaali tai muu yksinään tai
yhdistelmänä käytettävä laite tai tarvike sekä sen asianmukaiseen
toimintaan tarvittava ohjelmisto, jonka sen valmistaja on tarkoittanut
käytettäväksi ihmisen
a) sairauden diagnosointiin, ehkäisyyn, tarkkailuun, hoitoon tai
lievitykseen,
b) vamman tai vajavuuden diagnosointiin, tarkkailuun, hoitoon,
lievitykseen tai kompensointiin,
c) anatomian tai fysiologisen toiminnon tutkimiseen, korvaamiseen tai
muunteluun; tai
d) hedelmöitymisen säätelyyn,
Copywright Tom Ståhlberg
Lääkinnällinen laite (Medical device): määritelmä
….. ja joiden pääasiallista vaikutusta ihmiskehossa tai ihmiskehoon ei
saavuteta farmakologisin, immunologisin tai metabolisin keinoin, mutta
joiden vaikutusta voidaan tällaisilla keinoilla edistää.
This applies also for software and digital health!
Copywright Tom Ståhlberg
Software as an MD
the key = MD definition
”When the intended use is for the diagnosis of disease or other conditions, or
the cure, mitigation, treatment, or prevention of disease, or is intended to
affect the structure or any function of the body of man”
Finnish opportunities in
digital health technology
and regulatory restrictions
When is a software a medical
device?
What is the implication?
Can we live up to the demands?
Mobile apps as an example
Safety, safety, safety…
Copywright Tom Ståhlberg
Right from the beginning
Innovation not enough!
Before product development: marketing and regulatory strategy!
Take regulatory requirements into account from Day 1:
Product specific requirements
Quality Management System requirements
2. Which regulations apply? 1. Intended use 6. Declaration of conformity and CE marking 4. Essential requirements 3. Define risk class 5. Conformity assessment 7. Product registration Copywright Tom Ståhlberg
8. Throughout the product life cycle Product registration requirements: From Day 1!
www.reguloiko.fi
Finnish opportunities in
digital health technology
and regulatory restrictions
When is a software a medical
device?
What is the implication?
Can we live up to the demands?
Mobile apps as an example
Safety, safety, safety…
Copywright Tom Ståhlberg
Finnish Health Technology 2014
Export 1 800 milj. €
Growth 8.3 %
Regulations – from a trade barrier to a
competitive edge!
What about software business?
Remember: embedded software included in
almost all MDs!
Standalone? Not yet too much, but great
potential!
Suomessa paljon mahdollisuuksia...
1. Electro-diagnostic devices
GE Healthcare Oy
5. Medical aids
Respecta Oy
2. X-ray and radiology
Planmed Oy
6. In vitro-diagnostic equipment, systems, and reagents
PerkinElmer Wallac Oy
3. Medical furniture
Lojer Oy
4. Surgical, dental and other
therapeutic instruments
Planmeca Oy
7. eHealth, healthcare ICT
8. Health promotion and
consumer products
Mawell Oy
HUR Oy
FiHTA member companies
Acute Oy
Aidertech Oy
Ani Biotech Oy
Bioretec Oy
BoneIndex Oy
Clinius Oy
ClothingPlus Oy
Conforman Oy
CorusFit Oy
Delfin Technologies Oy
Desigence Oy
Diter-Elektroniikka Oy Ab
Elekta Oy
Emicaid Oy
Emfit Oy
Espotel Oy
Etteplan Oy
Finnmedi Oy
Franke Medical Oy
GE Healthcare Oy
Healthy Life Devices Oy
Horizon Wellness Oy
HUR Oy
Innokas Medical Oy
Kojair Tech Oy
Lewel Group Finland Oy
Lojer Oy
Mariachi Oy
Mawell Oy
Medfiles Oy
Medikro Oy
Medix Biochemica Oy Ab
Mega Elektroniikka Oy
Mendor Oy
Merivaara Oy
Mylab Oy
Nemko Oy
Nexstim Oy
Optomed Oy
Orion Diagnostica Oy
Oulu Wellness Institute
PerkinElmer Oy (Wallac)
Philips Medical Systems
Planmeca Oy
Relaxbirth Oy
RemoteA Oy
Sartorius Biohit Liquid Handling Oy
SGS Fimko Oy
Sondi Oy
Spark Ergonomics Oy
Stick Tech Oy
Sysdrone Oy
TeleChemistry Oy
Thermo Fisher Scientific Oy
VTT Expert Services
Suomen mahdollisuudet?
Erinomainen kilpailukyky
Maailman paras ICT-maa
kilpailukyky
Patentit
1.  Sija
3. sija
9. sija
Singapore, Ruotsi, Hollanti, Norja, Sveitsi,
Meitä ennen: Korea, Japani, Kiina, Sveitsi, Saksa, USA, Tanska.
Ruotsi 10. sija
UK, Tanska, USA, Taiwan
Copywright Tom Ståhlberg
The future is behind the corner!
Almost like science fiction
•  Visualization brain stimulation for guiding
devices
•  Patient data portals
•  Finnish BlindSquare software
•  3D-printing
•  Health games
•  Remote diagnostics and surgery
•  Health tourism
•  Mobile health apps
•  TYKS: ear diagnosis trial
Copywright Tom Ståhlberg
Finnish opportunities in
digital health technology
and regulatory restrictions
When is a software a medical
device?
What is the implication?
Can we live up to the demands?
Mobile apps as an example
Safety, safety, safety…
Copywright Tom Ståhlberg
Mobile (Medical) Apps
Mobile apps – software applications running on a mobile platform
(handheld, commercial off-the-shelf computing platform such as
smart phones, tablets or other portable computers, with or
without wireless connectivity)(or accessories attached to
such) or a web-based software application tailored to a mobile
platform but run on a server
> 100 000
US FDA
Mobile Medical Applications
Guidance for Industry and Food and Drug Administration Staff
US FDA focus
Focus its regulatory oversight on a subset of mobile medical apps with
greater risk to patients
The majority are thus not to be subject for enforced requirements under the
Federal Drug and Cosmetic Act (enforcement discretion)
no manufacturer licensing, no product filing
however, if goes wrong...
however, strong recommendations to have QMS according to QSR
When do regulations apply?
Mobile apps used for facilitating
health and wellness but which are
not medical devices
NOT a MD regulatory issue!
When do regulations apply?
Mobile Medical Applications, but low risk
US FDA Enforcement discretion
Mobile apps used for facilitating
health and wellness but which are
not medical devices
NOT a MD regulatory issue!
When do regulations apply?
Mobile Medical Applications, high risk
same regulations as for any medical device
Mobile Medical Applications, but low risk
US FDA Enforcement discretion
Mobile apps used for facilitating
health and wellness but which are
not medical devices
NOT a MD regulatory issue!
”Tailored approach supports innovation
while protecting consumer safety”
How can you know?
Separate lists:
Examples the FDA has cleared or approved
Examples for which the FDA will exercise enforcement discretion
In the Guidance:
Examples
that are not medical devices
Examples
enforcement discretion
Examples
FDA regulatory oversight focus
If in doubt:
US FDA web
Division of Small Manufacturers, International and Consumer Assistance
513(g) process: provides confidential written response within 60 days
(user fee, cover letter, apps description, description of use, proposed labeling
of the apps and possible similar legally marketed device)
SW and US FDA what else?
Level of concern
Data protection
HIPAA
GAMP
Radio-frequency wireless technology in MDs
Cybersecurity in MDs
Finnish opportunities in
digital health technology
and regulatory restrictions
When is a software a medical
device?
What is the implication?
Can we live up to the demands?
Mobile apps as an example
Safety, safety, safety…
Copywright Tom Ståhlberg
Medical errors are quite common
250,000 deaths per year are caused by medical errors, making this
the third-largest cause of death in the U.S., following heart disease
and cancer
Dr. Barbara Starfield, Johns Hopkins School of Hygiene and Public Health
Fortunately, only a few related to MDs!
Copywright Tom Ståhlberg
Products and services must be safe and effective
Copywright Tom Ståhlberg
Easy regulations not possible
Sääntelyn sujuvoittaminen?
Copywright Tom Ståhlberg
Regulations
Not necessary to make the
regulations less stringent
But: predictability and stability
obligatory
Copywright Tom Ståhlberg