January 31, 2014

CDS Coalition: SOFTWARE Act goes too far

The Clinical Decision Support (CDS) Coalition charges that a bipartisan bill introduced in October 2013 to amend the Federal Food, Drug, and Cosmetic Act “goes too far” in deregulating CDS software that requires regulation to ensure the health and safety of patients. Read more on the Coalition’s legislative proposal here:

April 16, 2013

POLITICO’s Tech Intersection: Health Care of the Future

Politico is hosting an interactive conversation about how innovative technologies are changing the policy and practice of health care.  Special guests include: Audie Atienza, Ph.D., NIH; Christy Foreman, FDA Office of Device Evaluation; Sridhar Iyengar, Ph.D., AgaMatrix; Jordan Shlain, M.D., Healthloop; Joe Smith, M.D., Ph.D., West Health; Bradley Merrill Thompson, mHealth Regulatory Coalition and Joel White, Health IT Now Coalition.

When: April 30th; 8 a.m.

Where: 901 K Street


February 25, 2013

Call to discuss strategies that MRC should pursue in EU

Date: Friday, March 8 Time: 11 am -12:30 pm (Eastern Time)/ 17:00 – 18:30 (Central European Time)

There are currently 5 hot topics that will impact EU regulations, and the way healthcare providers, telecommunication, software developers, pharmaceutical companies and medical device companies will do business and bring their products to the market:

  1. Wellness v. disease dichotomy, with disease use cases being regulated and wellness not
  2. Accessory issue: when if ever are the phone, software and hardware that plugs into the phone regulated as accessories
  3. Standalone software that aids in clinical decision-making
  4. Regulation of pharmaceutical apps: medication reminders, drug dosage calculators, tracking and compliance logs
  5. Privacy requirements for data collected in these mobile applications

The MRC would like to invite you to participate in a phone call with other US and EU thought leaders to discuss these issues, and the strategies that the MRC should pursue in EU.  This call will be to validate our perception of the regulatory issues and their impact on businesses. If the issues are indeed as important as we think, we will develop an action plan to address them that will be shared  in a second phone call.

Please contact Dana Pirvu at  if you would like to participate in this phone call. There is no cost or commitment associated with participating in this call.  We simply want to have a candid conversation among experts, and find the best ways to advocate mHealth specific issues.

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