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

© 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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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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A few definitions…

E-health / M-health

Internet of things / Connected devices / Quantified-self

3D printing

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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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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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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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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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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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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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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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Legal implications

Medical device qualification

Data protection issues

Trade mark issues

Contractual schemes

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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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Quizz – Is it a medical device?

[images withdrawn]

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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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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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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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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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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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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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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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The Perfect Match?

[image withdrawn]


Thank you for your attention. Any

questions?

Frédérique Potin

Senior Associate, Simmons & Simmons LLP

Paris

T +33 1 53 29 16 40

E [email protected]

Documents

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