Digital health solution providers, and users of digital health services, should take note of three recently launched EU public consultations in the digital health space, and may wish to make submissions to help shape the future of digital health initiatives in the EU. The earliest deadline for submissions is 16
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Data Transparency
ICO Rules UK Hospital-DeepMind Trial Failed to Comply with UK Data Protection Law
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’.
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EU Commission Creates New mHealth Data Quality Working Group
Following a 2014 mHealth consultation and two open stakeholder meetings in 2015 (see here and here), the European Commission has announced the formation of a new working group aiming to draft guidelines on mHealth app data quality.
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CMS Designates Chief Data Officer to Lead New Data and Analytics Office
The Centers for Medicare & Medicaid Services (CMS) announced in late November that it has designated the agency’s first “Chief Data Officer” to lead a new Office of Enterprise Data and Analytics (OEDA). Niall Brennan will serve as the agency’s CDO and his office will oversee “improvements in data collection…
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