The Premier Wireless CommunityLegal SIG‘Connected healthcare – connected to legality?’

28th January 2016

Network • Learn • Grow

© 2016 Cambridge Wireless Network • Learn • Grow3 May 2023

‘Braci's multipurpose platform’Juma El-Awaisi,

Chief marketing officer, Braci

www.braci.co

2 About Braci

Help deaf and people with hearing lossSoftwareDetect sounds and alert the users

360MPeople

3 Problem

And many more..

According to World Health Organization

4 Facts

50M

10M

1.8M 530MIn 2031 44

%

Worldwide

360MNow

5 The Solution

Philips Hue Notifications

Vibration Activated

Flashlight Activated

Pebble Watch Notifications

6 Braci Features

Noise Cancellatio

nTechnology

Power consumptio

n < 7%

Works Offline

Long distance detection

35M

Up to +1000 Sounds

pre-Installed( Smoke

and Monoxide Alarms )

Approximately one-third of people over 65 years of age are affected by disabling hearing

loss

8 People with Hearing Aids

Going to bed

Taking a shower

They have to remove it

£ 1,600

NO

NO

YES

Bellman Puzzle Detect

£ 40

Braci

£ 640

9 Competitors

Price

Number of sounds

Wearable notifications

Installation Required

Max 5 Sounds

Max 5 Sounds +20 Sounds

International Emergency

NO

NO

YES

Yes

Yes

NO

10 Business Model

Revenue Stream

Strategy

Braci App

Other forms of

Notifications

Organizations Manufacturers

Licensing of the Algorithm

Individuals

11 Business Model

Deaf & Hard of Hearing People who

snore

Parents

Universities

Deaf CentersHotels

City Councils Car

Manufactures

Smartphone Manufacture

s

OtherManufacture

s

Cyclists

ManufacturersOrganizations Individuals

Finalize the patent

Expand Commercially

R&D

12 £ 450,000

£

Key Achievements13

IP Protection

Awards Working with

14 Legal 

Claims Regulations IP Partnershi

p

Anwar Almojarkes

hCTO

AmrWanleyCreative Director

Juma El-awaisiSales and marketing Director

15 The Team

sa

sa

sa

sawww.braci.

coinfo@braci.co

BraciInc

BraciInc

16 Contact us

© 2016 Cambridge Wireless Network • Learn • Grow3 May 2023

‘Data protection issues in the context of wearables’

Ross McKeanHead of data protection practice

Olswang LLP

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Connected Healthcare:data protection issues in the context of wearables

Ross McKean, Partner, Olswang LLP28 January 2016

Data protection issues in the context of wearables 21

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Happy Data Protection Day!

3 May 2023Data protection issues in the context of wearables 22

| 3 May 2023Data protection issues in the context of wearables 23

• Why all the fuss about GDPR?• How does GDPR address health data?• Implications for wearables and connected health• Takeaways

Agenda

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The small print

3 May 2023Data protection issues in the context of wearables 24

• The text of GDPR may change before its formal publication in the EU Official Journal this summer (though only minor formatting changes are expected). This presentation is based on the latest public version of the text available here.

• GDPR is the output of 4 years of intense lobbying and negotiation in Brussels and is full of vague text and derogations allowing Member States to “gold plate”. There is currently no guidance or jurisprudence considering the practical application of GDPR. Organisations processing health data should therefore keep a watching brief as best practice develops and guidance is issued – and monitor Member State laws which are passed or retained concerning health data.

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What is GDPR?

3 May 2023Data protection issues in the context of wearables 25

• Europe’s new General Data Protection Regulation

• (Nearly) final text agreed in December following a marathon 4 year negotiation

• Expected to be published in the Official Journal in May / June this year and come into force in mid 2018 simultaneously in all 28 Member States

• Will replace the current Directive 95/46/EC and domestic laws implementing the Directive

• Completely changes the game for data governance

• 4% fines of annual worldwide revenue for failing to comply with new requirements

• Applies to more data (wider definition of personal data) and to more organisations (processors now caught + wider applicable law test)

• Enhanced rights for individuals• Tighter rules for valid consent• European-wide data breach notification

requirement• Extra paperwork• Extra compliance costs – including need

to appoint a DPO

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How does GDPR address health data?

3 May 2023Data protection issues in the context of wearables 26

• New definitions of “genetic data”, “biometric data” and “data concerning health”.

• All treated as special categories of data subject to additional protections (Article 9).

• Member States retain the right to “gold plate” GDPR requirements for these data categories (Article 9(5).

• Controllers require lawful ground to process – broadly the same as under the Directive

Lawful grounds for processing (Article 9)

• with explicit consent; or• necessary for [providing medical care]; or• necessary for reasons of public interest in

the area of public health [e.g. protecting against epidemics]; or

• Necessary for … scientific and historical research purposes or statistical purposes based on law which shall be proportionate to the aim pursued, respect data protection rights and safeguard fundamental rights [the “scientific research” ground]

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Implications for wearables and connected health

3 May 2023Data protection issues in the context of wearables 27

• Consenting challenges – consent is still the gold standard for lawful processing but there are challenges with wearables with smaller / no GUI and a higher standard for consent under GDPR. Contrast consent mechanic for clinical trial v. consenting on app download

• Purpose limitation challenges – much stricter proposals dropped. Further processing for scientific purposes is permitted so long as the framework for safeguards around scientific research is complied with. Significant “win” for scientific research community

New safeguards:

• Requirement for “data protection by design and by default” e.g. data minimisation and anonymisation.

• Mandatory data protection impact assessments for higher risk processing (limited exemptions)

More paperwork required:

• New rules for processing contract terms, policies and comprehensive record keeping.

New rights for individuals – though some exceptions where processing for scientific research

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Takeaways

3 May 2023Data protection issues in the context of wearables 28

• GDPR has largely been welcomed by the scientific community, though partly on the basis that it could have been much worse

• Connected health use cases using wearables and mobile applications are still feasible under GDPR but with the scale of fines proposed, full compliance is a must

• This is a particular challenge for many of the smaller innovators in eHealth and mHealth who do not have the same resources as large pharma and healthcare providers

• Review current processing practices and supply chain

• Justify and plan for transparency and consent

• Keep data to an absolute minimum; never collect personal data where annonymised or pseudonimsed data will suffice

• Focus on your supply chain – you need to ensure end to end compliance

• Assume data breach is going to happen – regularly – and build incident response governance teams and governance now. Test them

Thank you for listening

Olswang:Changing Business.www.olswang.com

Ross McKean / Partner / Head of Data Protection+44 (0)20 7067 3378

ross,mckean@olswang.com

Brussels+32 2 647 4772

London+44 20 7067 3000

Madrid+34 91 187 1920

Munich+49 89 206 028 400

Singapore+65 6720 8278

Paris+33 17 091 8720

Thames Valley+44 20 7071 7300

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