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'Connected healthcare - connected to legality?'
- 1. The Premier Wireless Community Legal SIG ‘Connected healthcare – connected to legality?’ 28th January 2016 Network • Learn • Grow
- 2. © 2016 Cambridge Wireless Network • Learn • Grow2 February, 2016 ‘Braci's multipurpose platform’ Juma El-Awaisi, Chief marketing officer, Braci
- 3. www.braci.co
- 4. 2 About Braci Help deaf and people with hearing loss Software Detect sounds and alert the users
- 5. 360M People 3 Problem And many more.. According to World Health Organization
- 6. 4 Facts 50M 10M 1.8M 530M In 2031 44% Worldwide 360M Now
- 7. 5 The Solution Philips Hue Notifications Vibration Activated Flashlight Activated Pebble Watch Notifications
- 9. 6 Braci Features Noise Cancellation Technology Power consumption < 7% Works OfflineLong distance detection 35M Up to +1000 Sounds pre- Installed ( Smoke and Monoxide Alarms )
- 10. Approximately one-third of people over 65 years of age are affected by disabling hearing loss
- 11. 8 People with Hearing Aids Going to bed Taking a shower They have to remove it
- 12. £ 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
- 13. 10 Business Model Revenue Stream Strategy Braci App Other forms of Notifications Organizations Manufacturers Licensing of the Algorithm Individuals
- 14. 11 Business Model Deaf & Hard of Hearing People who snore Parents Universities Deaf CentersHotels City Councils Car Manufactures Smartphone Manufactures Other Manufactures Cyclists ManufacturersOrganizationsIndividuals
- 15. Finalize the patent Expand Commercially R&D 12 £ 450,000 £
- 16. Key Achievements13 IP Protection Awards Working with
- 17. 14 Legal Claims Regulations IP Partnership
- 18. Anwar Almojarkesh CTO Amr Wanley Creative Director Juma El-awaisi Sales and marketing Director 15 The Team
- 20. © 2016 Cambridge Wireless Network • Learn • Grow2 February, 2016 ‘Data protection issues in the context of wearables’ Ross McKean Head of data protection practice Olswang LLP
- 21. | Connected Healthcare: data protection issues in the context of wearables Ross McKean, Partner, Olswang LLP 28 January 2016 Data protection issues in the context of wearables 21
- 22. | Happy Data Protection Day! 2 February, 2016Data protection issues in the context of wearables22
- 23. | 2 February, 2016Data protection issues in the context of wearables23 • Why all the fuss about GDPR? • How does GDPR address health data? • Implications for wearables and connected health • Takeaways Agenda
- 24. | The small print 2 February, 2016Data protection issues in the context of wearables24 • 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.
- 25. | What is GDPR? 2 February, 2016Data protection issues in the context of wearables25 • 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
- 26. | How does GDPR address health data? 2 February, 2016Data protection issues in the context of wearables26 • 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]
- 27. | Implications for wearables and connected health 2 February, 2016Data protection issues in the context of wearables27 • 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
- 28. | Takeaways 2 February, 2016Data protection issues in the context of wearables28 • 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
- 29. 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 *** ***