When we recently asked "who tames a global healthbot", we touched on the iceberg of Software as a Medical Device and the need to balance effective regulation with commercial imperatives like the rate of capital burn for startups looking to bring a new product to market. Since we're also on a product development journey for CleanM8 - a clinical toolkit for supporting recovery journeys - we're going to take a moment to share some effective tools that help shape your design and compliance focus.
We reference these in our work delivering events like HackingHealthTech and startup acceleration programs with Slingshot, but share them to help grow local capability for DigitalHealth innovation and export market potential.
Staying local - Australian guidance
http://accan.org.au/files/Grants/PeaceofMind/index.html is a guidance tool developed in 2017 by University of Sydney researchers to help understand privacy, security, consumer protection, financial and therapeutic goods compliance. It's a simple, fast and effective tool for working out your minimum regulatory obligations.
Looking to the USA - FTC coverage
https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool is a useful tool published in April 2016 for navigating the more complex US healthcare environment, HIPAA, data breach obligations but would benefit from updated guidance about the impacts of imminent EU GPDR obligations that start in May 2018 (see www.wired.co.uk/article/what-is-gdpr-uk-eu-legislation-compliance-summary-fines-2018)
Design for Transparency and IP Defence
We're seeing some really good thinking coming out of the Turing Institute in the UK, touching on why algorithm driven interventions need capacity for forensic oversight + audit, whilst also being mindful of the need to protect IP rights of the algorithm developers. Highly recommend following their work.
We reference these in our work delivering events like HackingHealthTech and startup acceleration programs with Slingshot, but share them to help grow local capability for DigitalHealth innovation and export market potential.
Staying local - Australian guidance
http://accan.org.au/files/Grants/PeaceofMind/index.html is a guidance tool developed in 2017 by University of Sydney researchers to help understand privacy, security, consumer protection, financial and therapeutic goods compliance. It's a simple, fast and effective tool for working out your minimum regulatory obligations.
Looking to the USA - FTC coverage
https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool is a useful tool published in April 2016 for navigating the more complex US healthcare environment, HIPAA, data breach obligations but would benefit from updated guidance about the impacts of imminent EU GPDR obligations that start in May 2018 (see www.wired.co.uk/article/what-is-gdpr-uk-eu-legislation-compliance-summary-fines-2018)
Design for Transparency and IP Defence
We're seeing some really good thinking coming out of the Turing Institute in the UK, touching on why algorithm driven interventions need capacity for forensic oversight + audit, whilst also being mindful of the need to protect IP rights of the algorithm developers. Highly recommend following their work.
Interesting @WiredUK article by @turinginst Fellow Prof. Jon Crowcroft on how differential privacy, homomorphic encryption, and #GDPR could help #consumers wrestle back control of their personal information https://t.co/sYMFuqgh70
— The Turing (@turinginst) February 5, 2018
Check out my new paper w/@b_mittelstadt and Chris Russell on how to offer 'counterfactual explanations' for AI based decisions without opening the black box and to create explainable and accountable AI https://t.co/VzDHihL6Cn @oiioxford @turinginst @oxfordethicslab #aiethics
— Sandra Wachter (@SandraWachter5) January 8, 2018
See @turinginst Fellow @tforcworc's article on #GDPR and the use of differential privacy, homomorphic encryption and 'edge cloud' approaches to ensure companies use citizens' data in a privacy-preserving way https://t.co/gGQIUSvRzj
— Helena Quinn (@h_s_quinn) February 5, 2018
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