Branding & Regulatory challenges for apps and web-based … · 2016-03-22 · Branding & Regulatory challenges for apps and web-based platforms…are you connected? PTMG 92nd Spring
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Branding & Regulatory
challenges for apps and web-
based platforms…are you
connected?
PTMG 92nd Spring Conference
London, 15 March 2016
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
What is this presentation about?
A few definitions and examples
Internet of things, ehealth, mhealth, connected devices, 3D printing…all you
ever wanted to know about them but never dared to ask…
From sport apps to ingestible drugs and 3D human skin
Legal implications
– What is the legal nature of apps and connected devices in the pharma
industry?
– How to handle health data?
– Whose trade mark will protect them?
– How to contractualise schemes between pharma companies and IT
developers?
Conclusion
Towards personalized care…
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
A few definitions…
E-health / M-health
Internet of things / Connected devices / Quantified-self
3D printing
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
E-health
According to the World Health Organization, E-health can be defined as the
transfer of health resources and health care by electronic means. It
encompasses three main areas:
The delivery of health information, for health professionals and health
consumers, via the Internet and telecommunications networks.
Using the power of IT and e-commerce to improve public health services, e.g.
through the education and training of health workers.
The use of e-commerce and e-business practices in health system
management.
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
M-health
The World Health Organization defined m-health as a practice of medicine and
public health supported by mobile devices, i.e. using mobile communication
devices, such as mobile phones, tablet computers and PDAs, for health
services and information (Source: WTP Report New Horizons for Health and
Mobile technologies, 2011).
M-health applications include the use of mobile devices in collecting community
and clinical health data, delivery of healthcare information to practitioners,
researchers, and patients, real-time monitoring of patients’ vital signs, and
direct provision of care (via mobile telemedicine)
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Internet of things and Connected device
“Internet of things” is an expression which links two different worlds: the
“Internet”, a world made of immaterial, applied to “things”, i.e. objects
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Quantified-self
The “quantified-self” refers to a number of practices which enable individuals to
measure and compare information relating to their life habits with that of others
e.g. number of steps per day, physical activities, quality of sleep etc.
Use of bracelets, watches, pedometers, apps for mobile phones.
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
3D Printing
3D printing is a process which enables the reproduction of an object by binding
successive layers of materials.
Objects are produced using an electronic data file and a specific software
The raw material can be of multiple sorts: plastic, metal, ceramic, organic
Can be used to reproduce human organs, such as implants or to prepare
surgery and to manufacture drugs (e.g. SPRITAM, first pills manufactured using
3D printing, authorized by the FDA in August 2015)
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
A few stories : ABILIFY & PROTEUS
When the drug with the embedded ingestible sensor is taken, the sensor sends
a signal to a patch after it reaches the stomach
The patch records and time-stamps the information from the ingestible sensor
in addition to collecting other patient metrics, including rest, body angle and
activity patterns.
This information is recorded and relayed to patients on a mobile phone or other
Bluetooth-enabled device, and with their consent, to their physician and/or their
caregivers.
Patients view the information using a secure and local software application on
their mobile phone or device. Physicians and caregivers view the data using
secure web portals.
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
A few stories : MEDISSIMO
Creation of a connected pills dispenser to avoid mistakes and over-
consumption issues
The pharmacist places the relevant pills in the connected dispenser
The patient connects the dispenser to a specific box using GPRS technology.
The Medissimo e-health platform records each time the patient takes a pill
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Legal implications
Medical device qualification
Data protection issues
Trade mark issues
Contractual schemes
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Medical device - Qualification
Criteria to qualify as a medical device: intended by the manufacturer to be used,
alone or in combination, for human beings for one or more specific medical
purposes
Classification of connected devices:
Device for well-being purposes: measure parameters + use of connected apps
Device with medical purpose: certified measure of parameters + use of
connected apps + diagnosis, recommendations and monitoring
Classification of software:
Referred to in the definition of “medical device” (Draft Regulation on Medical
device)
Use of MEDDEV graphic chart
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Quizz – Is it a medical device?
[images withdrawn]
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Data protection – Sensitive Data
Digital health necessarily implies access, use, processing and storage of
personal data
– Data relating to the identity of the user (name, email address, mobile phone
number) for communication purposes
– Data relating to the health of the user = “sensitive data” An extensive definition of “data concerning health”
“all data pertaining to the health status of a data subject which reveal
information relating to the past, current or future physical or mental health
status of the data subject; including information about the individual collected in
the course of the registration for and the provision of health care” (New EU Regulation – Recital 26 + Definition)
The processing of “sensitive data” is prohibited subject to specific exceptions
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Data Protection – Issues
Possibility to process health-related data in limited circumstances, in the
context of M-health:
– Consent of the data subject
– Processing is in the direct interest of the patient or in the public interest
(e.g. for the purpose of providing remote medical services)
Implementation of security measures to avoid unauthorized access and use of
the data
Information of the patient/user on the processing of their data and of the
categories of persons having access to their data
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Trade marks
Pharma companies filing for Class 9, 10 and 38?
Extension of clearance searches to new classes
Extension of trade mark protection
Costly?
IT companies filing for Class 5 and 10?
Organize contractual arrangements
Obtain guarantees that relevant clearance was conducted
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Example: ABILIFY by Otsuka
New CTM application ABILIFY MIVU in 2014 covering:
9: Computer application software for mobile phones, tablets, portable electronic devices and
handheld computers for use in collecting and storing patient data and medical information
including drug ingestion information, pulse, heart rate, respiratory rate, body temperature,
electric pressure in the body, human motion, human position or sleeping condition from a
sensor attached to the patient's body.
10: Sensor patches attached to the patient's body for use in measuring, collecting and storing
patient data and medical information including drug ingestion information, pulse, heart rate,
respiratory rate, body temperature, electric pressure in the body, human motion, human
position or sleeping condition.
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Example: VERILY by Google, Inc
Recent CTM application for VERILY by Google, Inc., covering:
5: Pharmaceutical preparations.
7: Incubators for medical purposes.
9: Wearable computing devices; wearable computing devices for the detection and treatment of
diseases; computer software and computer programs for use in the medical, scientific and
pharmaceutical fields; clinical trial software; computer hardware and software for medical
imaging apparatus; clinical trial data collection, storage and analysis software; data processing
equipment; computer software for surgical equipment; health data security and privacy
software; computer software and computer programs for transmission of medical and scientific
data and information; contact lenses.
10: Surgical, medical, dental and veterinary instruments and apparatus; scientific instruments
and apparatus; surgical tools and instruments; instruments and apparatus systems for medical
diagnostic uses; medical imaging apparatus; surgical robotics; drug delivery systems; medical
devices; intraocular lenses; medical devices for the prevention, diagnosis and treatment of
diseases.
38: Electronic transmission and reception of messages and data; electronic transmission and
reception of information in the medical, scientific, healthcare and pharmaceutical fields.
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Contractual issues
Implementation of contracts to cover relationships between IT developers and
the pharma industry
Development agreements
– Confidentiality provisions
– Ownership of IP rights on the device or software
– Liability issues
Services agreement for hosting of health data, anonymisation processes,
analyzes of big data
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Conclusion
Apps and connected devices are the necessary tools for personalised care
3D printing will enable individuals to manufacture or have their drugs
manufactured next door
For pharma companies, this may mean adopting new internal processes
involving individuals who belong to different teams/worlds at the outset of the
project: trade mark lawyers, IT engineers, patent lawyers, compliance and
regulatory teams
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
The Perfect Match?
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© Simmons & Simmons LLP 2013. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Thank you for your attention. Any
questions?
Frédérique Potin
Senior Associate, Simmons & Simmons LLP
Paris
T +33 1 53 29 16 40
E frederique.potin@simmons-simmons.com
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