mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes
For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the legal and regulatory landscape in which mHealth technologies reside is only now beginning to take shape.
As mHealth developers, funders and even users consider investing in the field, or including in particular mHealth technologies, they should keep in mind the emergent and fluid nature of the mHealth regulatory landscape. Here, we outline the likely key players and discuss several recent and projected initiatives with respect to the oversight of mHealth technologies:
Welcome to Blawg Review #260
The Genomics Law Report is pleased to host the 260th Blawg Review. For regular GLR readers who are unfamiliar with the Blawg Review concept, it’s the longest-running weekly recap of legal blog posts in cyberspace. Each week, a different legal-related blog (also referred to as a blawg or, in the GLR’s case, an Internet journal) hosts Blawg Review, highlighting the most interesting posts from the previous week. Think of it as an enhanced version of our regular Weekly Twitter Roundup.
The occasion for this week’s Blawg Review is DNA Day 2010. For regular Blawg Review readers who may not be familiar with DNA Day, the event was established by Congressional resolution in 2003 to commemorate the 50th anniversary of the description of the double-helix structure of DNA and to celebrate the publication of the final consensus human genome sequence produced by the Human Genome Project.
This year’s DNA Day (April 23rd) is generating more publicity than usual as it coincides with the 10th anniversary of the draft human genome sequence. (Perhaps it makes sense to peg anniversary celebrations to the draft publication, as the final human genome sequence is still being completed seven years after its publication.) Many of the genomic pioneers from this past decade, as well as decades prior, will be gathering in Cambridge, MA next week at the GET Conference to take stock of how far the science and commerce of genomics has come, and project where it is heading in the decades to come.
So, pick your favorite anniversary – 57 years since the double helix, 10 years since the draft genome, 7 years since the final genome or 5 years since the first Blawg Review – and join us as we looks back at the week that was in blawging.
What the FCC’s Broadband Report Means for Genomics and Personalized Medicine
The Federal Communications Commission’s (FCC) National Broadband Plan was released to Congress today. (Depending on your perspective, that’s either one day ahead or 30 days behind schedule.) What, you might ask, does a broadband report prepared by an agency better known for handing out fines in the aftermath of wardrobe malfunctions have to say that could possibly interest the Genomics Law Report?
For most of the broadband plan’s 376 pages (pdf) the answer is “nothing at all.” However, Chapter 10 focuses on Health Care (pdf), with several discussions of potential relevance to the future of genomics and personalized medicine, at least in the United States. The bulk of the chapter is devoted to issues of indisputable importance – e-care, health IT, mobile and rural healthcare delivery, for instance – that will be capably covered elsewhere. (mobihealthnews, for instance, is already providing coverage of aspects of the plan that will impact mobile health care: here and here.) However, Section 10.4 (“Unlocking the Value of Data”) offers up two important themes that are relevant to how at least one government agency views the future of genomics and personalized medicine.
