On 5 September, in response to the opportunities presented by data-driven innovations, apps, clinician decision support tools, electronic health care records and advances in technology such as artificial intelligence, the UK Government published a draft “Initial code of conduct for data-driven health and care technology” (Code) for consultation. The Code is designed to be supplementary … Continue Reading
On 1 May, 2018 the Centre for Policy Studies (the “CPS”) published its latest paper on the UK’s National Health Service (the “NHS”) entitled “Powerful Patients, Paperless Systems: How New Technology Can Renew The NHS” (the “Paper”). The Paper advocates a “digital first NHS” that adopts a paperless system and enables patients to take full … Continue Reading
On the April 25, 2018 the European Commission (the “Commission”) adopted a plan of action to enable the digital transformation of health and care in the Digital Single Market (the “Communication”), intended to put EU citizens at the centre of the healthcare system. This is to be achieved in three ways: 1. Citizens’ secure access … Continue Reading
In the second of a three-part series, Covington’s global cross-practice Digital Health team considers some additional key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Commercial Questions When Contracting for Digital … Continue Reading
On August 30, the UK government published a report by Professor Sir John Bell of Oxford University providing a number of recommendations to government to ensure the long term success of the life sciences sector in the UK (Life Sciences Industry Strategy). This blog post summarises the key recommendations and observations made from a digital … Continue Reading
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 August 2017. EU Commission Transformation … Continue Reading
Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a final mark-up of legislation comprising the Committee’s counterpart to the House-passed 21st Century Cures Act. The HELP Committee approved five bills including S. 2713 to advance the development of “precision medicine” through research and data sharing. We have reported on the President’s precision medicine … Continue Reading
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.… Continue Reading
In a 107-page report, released last week, the White House set forth its plan to create and manage a database containing 1 million or more Americans’ medical records in furtherance of the Precision Medicine Initiative. As announced by President Obama during his 2015 State of the Union Address, the Precision Medicine Initiative was launched “to … Continue Reading
On April 29, 2015, members of the U.S. House Energy and Commerce Committee released a revised discussion draft of the 21st Century Cures Act (“Cures”). The draft bill includes a number of provisions intended to facilitate drug, biologic, and medical device discovery and development through greater collection and dissemination of data and the use of … Continue Reading
As we described in an a post last month, in the State of the Union the President announced a new “Precision Medicine Initiative” to foster the development and delivery of personalized treatments for illnesses such as cancer and diabetes. The FY 2016 budget released by the President yesterday includes $215 million in funding to launch … Continue Reading
This year’s State of the Union address included little explicit discussion of health IT, but did highlight two areas that could have significant implications for health IT: the President announced a new “Precision Medicine Initiative” and also urged Congress to pass legislation to combat cyber attacks and prevent identity theft. While the address was scant … Continue Reading
The excitement around eHealth innovations was palpable throughout San Francisco this week as the annual JP Morgan healthcare conference flooded the city. JP Morgan itself offered panels and presentations from industry leaders and emerging companies, while simultaneously occurring conferences, speaker programs, and networking events throughout San Francisco featured discussions on the changing face of healthcare … Continue Reading