digital health: how can law facilitate innovation in … · personalized medicines – customized...

29 MARCH 2019 POST DOC

KALPANA TYAGI

AARHUS UNIVERSITYDEPARTMENT OF LAW

DIGITAL HEALTH:HOW CAN LAW FACILITATE

INNOVATION IN THE CONVERGED

ICT/HEALTHCARE?

KALPANA TYAGI

29 MARCH 2019 POST DOC AARHUS UNIVERSITYDEPARTMENT OF LAW

OUTLINE

Defining The Digital Health/‘Internet of Things in Healthcare’/e-Health?

Why (?) the Digital Health

From macro to micro

Key Issues & Insights from research

KALPANA TYAGI


WHAT IS THE INTERNET OF THINGS

[Robin Stitzing, Nokia, Member of 4iiP Council, The Internet of Things and 5G: An Overview, p.3]

KALPANA TYAGI


DIGITAL HEALTH: WHAT?

KALPANA TYAGI


DIGITAL HEALTH: WHAT?

IoT in Healthcare

e-Health

Refers to the emerging healthcare ecosystem that comprises of many distinct, but inter-related concepts, namely:

m-health – use of mobile phones & other wireless technology. Include applications – create awareness, monitoring apps, diagnostic support

tele-health – remote conversation over phone (mobile/landline/apps such as Skype) between the patient and clinician. – For long terms conditions

KALPANA TYAGI


DIGITAL HEALTH

health- informational technology – computer & server managed systems (normally by hospitals) – to facilitate secure exchange of information between patients and medical experts

wearables – clothing & accessories that collect data may offer real time feedback and offer personalized care. Eg. Activity trackers, hearing aids

personalized medicines – customized medication that takes due account of the differences in individual genetic make up.

tele-medicine/telecare - use of mobile/landline/apps such as Skype for remote care – possible for regular care, critical care and emergency situations

KALPANA TYAGI


DIGITAL HEALTH: WHY? BETTER CLINICAL OUTCOMES

“Peer mentorship is a cost effective way of improving glycemiccontrol. In a study done with participants with out-of-control diabetes, those who received weekly contact from a peer mentor had a statistically significant decrease in HbA1c levels by 1.08 points while those with usual care had no improvement.” - Key point: Between peer mentorship and financial incentives, an occasional reprimand by the peers way more effective to control and stay healthy.

Long et al, Peer Mentoring and Financial Incentives to Improve Glucose Control in African American Veterans 2012; 1546: 416-424

KALPANA TYAGI


DIGITAL HEALTH: WHY?

Shortage of 13 million healthcare workers worldwide (WHO, 2013)

Number of mobile connections 7.6 billion worldwide (ITU 2016)Healthcare + Digital = “scalable, evidence-based and

integrated health solutions” that yield long-term healthcare benefits

KALPANA TYAGI


DIGITAL HEALTH: BY WHOM? -KEY STAKEHOLDERS (1/3)

By the year 2016, 151 of 196 Member State Countries had national broadband plans.

Out of this 73 had developed eHealth Strategies

76 had developed electronic health record systems

66 had a developed national telehealth policy.

Each country has its own rational for & how to develop an e-health strategy.

KALPANA TYAGI


GOOGLE FIT: GOOGLE/WHO PROJECT

71st World Health Assembly: participating governments recognize that digital technology can be a key enabler in achieving the Sustainable Development Goal No.3 Good Health and Well Being for All by 2030

WHO recommendation for 16-54: 150 minutes of moderate intensity or 75 minutes of vigorous intensity, aerobic physical activity or a combination of both

Benefits: Lower rates of hypertension, overweight and obesity; better mental health and overall well-being and quality of life.

KALPANA TYAGI


HEALTHCARE FOR ALL & MERGER CONTROL (COMPETITION POLICY)

ICC’S GLOBAL ANTITRUST REVIEW, ISSUE 11, 2018, pp 33 ff.

KALPANA TYAGI


GOOGLE FIT: GOOGLE/WHO PROJECT

Worked with the WHO & the American Heart Association (AHA) to understand the science behind physical fitness and health.

Two goals:

Move Minutes: Overall time spent moving and stood upright. – Impact – If imbalance, user may walk, rather then drive to office.

Heart Points: Uses game theory (!) to look at & motivate the intensity of research. – Ex. 1 point for each minute of moderate intensity – ex. walking the dog. More intense the activity, higher the points gained for each minute of activity.

Based on the insights from a WHO study, Google collaborates with the organization to develop a fitness app tied to the Google Account

KALPANA TYAGI


CONFIRM RX

Combines smartphone and integrated symptom recorder

myMerlin app – records symptoms in real time & in case of irregular heart beat, immediately alerts the doctor.

Encrypted and secure transmission of information.

Keeps the user connected to the healthcare provider.

Registered as a Medical Device

Received in Oct’2017: US Food and Drug Administration (FDA) clearance – as the world’s first & only smartphone compatible Insertable Cardiac Monitor designed for the remote identification of cardiac arrhythmias.

THE WORLD’S FIRST SAMRTPHONE-ENABLED CARDIAC MONITOR“Many things can interrupt your life.

We believe heart monitoring does not have to be one of them.”

KALPANA TYAGI


-SANOFI/GOOGLE/JV

ONDUO: Joint Venture between Sanofi & Google (Verily)

Services for the management and treatment of diabetes, including data collection and processing and data analysis.

Reviewed by the European Commission under Merger Regulation 139/2004

Five Relevant Markets identified: Insulin, Insulin Delivery Systems (such as insulin pumps), Glucose Monitoring Systems, Services for the management & treatment of diabetes using an integrated digital e-medicine platform and data analytic services.

Excerpt from Kalpana Tyagi, Promoting Competition in Innovation pp 323 ff (forthcoming).

KALPANA TYAGI


GE/ROCHE: DIGITALIZED MEDICINE PORTFOLIO

GE: Medical Imaging and monitoring equipment that delivers rich amount of patient data. (2003/2004 under Regulation 4064/89: Two significant consolidations in the sector: GE/Instrumentarium and Siemens/Drägerwerk/JV in the field of critical care–both conditionally cleared by the European Commission)

Roche’s ‘bio-marker, tissue pathology, genomics and sequencing portfolio’ – key insights into the value of oncology offerings.

Traditionally Roche’s strategy: ‘science-based horizontal axis’ strategy to leadership. –Developing a disruptive breakthrough technology with wide

applicability across a range of therapeutic areas.

KALPANA TYAGI


GE/ROCHE: DIGITALIZED MEDICINE PORTFOLIO

GE & Roche JV: Develop a joint software solution for clinical support in oncology and intensive care.

GE/Roche: proprietary digital oncology platform – to develop a digital solution that will facilitate clinical decision-making in oncology and intensive care.

Medication based on profile and data

KALPANA TYAGI


IOT IN HEALTHCARE….

Dmitry Budko, How Blockchain Can Transform Artificial Intelligence, dt 13 February 2018 https://dzone.com/articles/how-blockchain-can-transform-artificial-intelligen,

https://dzone.com/articles/how-blockchain-can-transform-artificial-intelligen

KALPANA TYAGI


COMMON TO ALL: DATA

Personal data: GDPR – key consideration respect for privacy of the data subjects.

Article 15 GDPR: Right of access by the data subject – right to obtain from the controller confirmation as to whether or not personal data concerning him/her being processed, and if yes, access to personal data

Article 20 GDPR: Data portability right – Right to receive personal data .. s/he which provided to the controller… in a structured, commonly used and machine-readable format … and have the right to transmit those data to another controller …

Data: Personal and non-personal – but is it really possible to clearly distinguish the two? –Emerging technological tools to de-anonymize data.

Data protection and the data producer’s right – Commission’s view: offer precedence to data protection rights including the right to erasure – but then, how effective will be the ‘legislation on data producer’s right’?

KALPANA TYAGI


COMMON TO ALL: DATA

How about data access rights????

Digital health: data generated in complex environment driven by innovation – Data generated because the technology facilitates it.

Data relevant because well-developed algorithms that make meaningful interpretations from this data.

Other users too contribute to this data pool

-- Hence, the value of data. & data lock-ins more prevelant

Allocation of rights thus, troublesome and may in fact be anti-innovation

“central point of data collection” defined by health policies taking due account of the patient’s data protection rights + right to do business (but not undermined by theeconomic rights of the pharma’ (Data Access and Control, Drexl, pp. 35 ff)

AARHUS UNIVERSITYDEPARTMENT OF LAW

digital health: how can law facilitate innovation in … · personalized medicines – customized...

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