September 13, 2013

Enhancing Innovation in eHealth Systems Approach

This white paper outlines some factors related to innovation that the agencies, and in particular FDA, should consider as they put together the government’s strategy. More specifically, it identifies outdated aspects of the existing FDA regulatory framework and suggests significant changes to address the unique aspects of health IT. It also advocates for a holistic approach among FDA, FCC and ONC to avoid confusion, duplication and regulatory conflict.

July 18, 2013

Clinical Decision Support Proposed Regulatory Framework

CDS is a critical and growing part of healthcare. It includes a broad range of products with varying degrees of risks, from body mass index calculators to complex radiation dosage. The CDS Coalition believes that all CDS cannot be treated the same way from a regulatory perspective – and many low risk CDS products should not be actively regulated at all.

In 2011, FDA announced it is developing guidance on the regulation of clinical decision support software. For the past year and a half, the CDS Coalition has been working on a proposed regulatory framework that takes into account the unique aspects of CDS and helps ensure that CDS software will not become over-regulated.  On July 17th the Coalition held a webinar to gather additional input on their framework so that the Coalition can provide FDA a comprehensive proposal that reflects the views of patients, provider and others in the industry.

Slides from the webinar are available here: If you have feedback on the framework please direct them to Kim Tyrrell-Knott at

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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