On December 12, 2019, the European Parliament endorsed a non-binding resolution on enabling the digital transformation of health and care. The resolution calls on the European Commission to take a number of actions to foster the development of digital health systems in Europe to improve patient care and support research efforts — particularly those using innovative technologies such as AI.
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Digital Health
HHS Clarifies HIPAA Liability for EHR System Developers that Transfer Data to Health Apps
By Lindsay Brewer on
On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances under which electronic health record (EHR) systems may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) liability for an app’s impermissible use or disclosure…
IoT Update: The UK publishes a final version of its Code of Practice for Consumer IoT Security
By Inside Privacy on
By Grace Kim and Siobhan Kahmann
Following an informal consultation earlier this year – as covered by our previous IoT Update here – the UK’s Department for Digital, Culture, Media and Sport (“DCMS”) published the final version of its Code of Practice for Consumer IoT Security (“Code”) on October 14, 2018. This was developed by the DCMS in conjunction with the National Cyber Security Centre, and follows engagement with industry, consumer associations, and academia. The aim of the Code is to provide guidelines on how to achieve a “secure by design” approach, to all organizations involved in developing, manufacturing, and retailing consumer Internet of Things (“IoT”) products. Each of the thirteen guidelines are marked as primarily applying to one or more of device manufacturers, IoT service providers, mobile application developers and/or retailers categories.
The Code brings together what is widely considered good practice in IoT security. At the moment, participation in the Code is voluntary, but it has the aim of initiating and facilitating security change through the entire supply chain and compliance with applicable data protection laws. The Code is supported by a supplementary mapping document, and an open data JSON file which refers to the other main industry standards, recommendations and guidance. Ultimately, the Government’s ambition is for appropriate aspects of the Code to become legally enforceable and has commenced a mapping exercise to identify the impact of regulatory intervention and necessary changes.
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Digital Health Checkup: Key Questions to Consider in the Digital Health Sector
By Inside Privacy on
Posted in Health Privacy
Covington’s global cross-practice Digital Health team has posted an illuminating three-part series on the Covington Digital Health blog that covers key questions entities should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle.
- In the first part of the series, the Digital Health team answers
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Digital Health Check-Up: Key Questions Market Players Should Be Asking
By Inside Privacy on
Posted in Health Privacy
On our sister blog, CovingtonDigitalHealth, our global cross-practice digital health team has launched a three-part series on the key questions the technology, life sciences and communications industries should be considering as they fit together the regulatory and commercial pieces of the complex digital health puzzle. Read the first post in the series here.
ICO Rules UK Hospital-DeepMind Trial Failed to Comply with UK Data Protection Law
By Joshua Gray on
Posted in Health Privacy, United Kingdom
The UK Information Commissioner’s Office (“ICO”), which enforces data protection legislation in the UK, has ruled that the NHS Royal Free Foundation Trust (“Royal Free”), which manages a London hospital, failed to comply with the UK Data Protection Act 1998 in providing 1.6 million patient records to Google DeepMind (“DeepMind”), requiring the Royal Free to sign an undertaking committing to changes to ensure it is acting in line with the UK Data Protection Act.
On September 30, 2015, the Royal Free entered into an agreement with Google UK Limited (an affiliate of DeepMind) under which DeepMind would process approximately 1.6 million partial patient records, containing identifiable information on persons who had presented for treatment in the previous five years together with data from the Royal Free’s existing electronic records system. On November 18, 2015, DeepMind began processing patient records for clinical safety testing of a newly-developed platform to monitor and detect acute kidney injury, formalized into a mobile app called ‘Streams’.
Continue Reading ICO Rules UK Hospital-DeepMind Trial Failed to Comply with UK Data Protection Law
European Cloud in Health Advisory Council Calls For Review of eHealth Rules and Ethics of Medical Data Re-Use
By Inside Privacy on
In a new post on the Covington Digital Health blog, our colleagues discuss a new European Cloud in Health Advisory Council whitepaper calling for a review of European healthcare data protection rules holding back greater adoption of cloud computing and AI; and for more discussion about the ethics and governance of re-use of patient…