By Dan Haley, VP of Government Affairs, athenahealth
In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”). The Agency solicited and received public comment. Thereafter began a nearly two-year waiting game that continues to this day and has more than a few mobile...
By Bradley Merrill Thompson
I feel like a dissident trying to convince the government to free a political prisoner. That’s a pretty apt description, considering that the FDA’s Mobile Medical App (MMA) guidance document is being held hostage purely on political grounds.
Earlier this year, a DC advocacy group decided they wanted Congress to adopt an entirely different approach to health IT. The...
FutureMed is a one of a kind program that educates, informs and prepares physicians, innovators, inventors, investors and senior healthcare executives to understand and recognize the opportunities and disruptive influences of exponentially growing technologies within medicine and healthcare.
Healthcare is ripe for disruption, and technology is breaking the traditional silos which have defined its...
Marcelo Calbucci is the Co-founder & CTO of EveryMove and a former development manager at Microsoft
Here is a bold statement: No other device, with the exception of the smartphone, will do more for the evolution of health technology than the Kinect 2.0 on the new Xbox One.
In case you are not a gamer or didn’t follow the news, the new Kinect comes packed with lots of high-end gear like a high...
By Bradley Merrill Thompson
As MobiHealthNews reported earlier, this week FDA sent an enforcement letter to the developer of a urinalysis app. This might sound weird, but I believe that’s good news for the mobile health industry.
Full disclosure, I may have played a part in FDA’s decision to send that letter. Over the last several months, I’ve had four occasions to talk about the app publicly,...
By Dave Dickinson, Former CEO, Zeo
After leading Zeo for the last 5 years, I'd like to share some of the key lessons we learned as an early pioneer within the digital healthcare movement. This post includes lessons learned for those who share our mission of improving the health and wellness of mankind by leveraging the awesome power of technology. Hopefully, some thoughts will engage new ways of...
By Bradley Merrill Thompson
As I said in the prior post, this series is for two types of companies: (1) those that are merely dipping their toes into mHealth because they’re afraid of the water, and (2) those that are diving right in head first with no idea how deep the water is. Both types of companies might be making mistakes, either by letting good opportunities go by or by incurring undue...
By Bradley Merrill Thompson
Some technology companies are sitting on the sidelines, or just dipping their toes in the mHealth waters, out of fear of the unknown. Will FDA regulate this space? If we get into healthcare, will we get sued if someone breaks a finger nail using our app? Will the FTC come after us if we don’t have a bunch of clinical trials to support every claim we make? Will a...
By Bradley Merrill Thompson, EpsteinBeckerGreen
I’ve always found the saying, “Be careful what you wish for; you might just get it” to be rather condescending. In a way it suggests that we are too stupid to manage our own affairs. But like any popular saying, it probably has a kernel of truth.
Frankly, I’m a little nervous about a request made by industry for international medical device...
Sponsored by: AHIP
As health plans navigate the changes to our health care system, including the role of new technologies, thousands of health care stakeholders will connect, converge, and collaborate at Institute 2013, June 12-14.
General Sessions:
Meeting Expectations in a Changing Health Care System: Stakeholder PerspectivesGeorge C. Halvorson, Chairman/CEO, Kaiser PermanenteCavan M. Redmond...
