On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
New FCC Task Force Gearing Up to Encourage Broadband-Enabled Healthcare Solutions
In announcing the formation of the Task Force in March 2014, FCC Chairman Wheeler explained that it was charged with “bring[ing] together the expertise of the FCC on the critical intersection of broadband, advanced technology, and health.” Former Enforcement Bureau Chief Michele Ellison serves as its Chair; the agency has not yet named additional Task Force members. According to the FCC’s press release, key jobs for the Task Force will be identifying regulatory barriers and incentives for greater adoption of health care technologies, and building stronger partnerships with stakeholders in the fields of tele-health, mobile applications, and tele-medicine. The Task Force’s first blog post, issued last week, focused generally on the potential of mobile health tools to improve patient outcomes, reduce health disparities, and lower medical costs.
When the Task Force starts holding its first meetings with stakeholders in late April 2014, it will follow several other interrelated health care initiatives at the agency. In 2012, then-Chairman Julius Genachowski announced the formation of an mHealth Task Force as a public-private partnership dedicated to ensuring that by 2017 mobile health technology is a routine part of medical practice. The mHealth Task Force produced a Report in September 2012 that included a series of recommendations regarding the role the agency should play in increasing the adoption of mobile health technologies, including building on government and industry efforts to increase the capacity, reliability, interoperability, and safety of mHealth technologies. The mHealth Task Force has been quiet since the release of its Report, and one possible role for the CONNECT2HEALTHFCC Task Force could be assuming the responsibility for seeing the recommendations of its predecessor through.
Another possible role for the Task Force could be reviewing a number of interrelated medical technology projects administered by the FCC under the umbrella of the Rural Health Care Program, including the Healthcare Connect Fund (“Fund”). The Fund was introduced in 2012 to improve medical provider access to broadband and to encourage the formation of state and regional broadband health care networks, and provides support to both rural and non-rural public and non-profit health care providers for broadband services, network equipment, and in the case of health care providers operating as consortia, constructed and owned network facilities. The FCC is currently seeking comment on ways to allocate the Fund to support consumer-oriented rural broadband “experiments” that would improve patient access to health care by providing funding for broadband connections.
The FCC appears poised to maintain its focus on increasing the adoption of healthcare related technology in the months to come. Stakeholders interested in exploring the agency’s direction further by meeting with the CONNECT2HEALTHFCC Task Force can send a request to engageC2H@fcc.gov, while general recommendations regarding the structure and scope of the Task Force should be e-mailed to firstname.lastname@example.org.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017