Active Months Ahead For mHealth Regulatory Policymaking
This article was originally published in The Pink Sheet Daily
Executive Summary
Multiple guidances, frameworks and legislative activity on mHealth are expected to surface this fall and could have major implications on how the emerging industry is regulated.
You may also be interested in...
IRB, HIPAA Changes To Be Folded Into 21st Century Cures Bill Next Year
Centralized institutional review board approvals for device trials, and removal of HIPAA privacy provisions that block registry data-sharing are among the ideas that are likely to make it into a draft bill planned for release in January as the next step in the House’s 21st Century Cures initiative.
Software Oversight Softened: FDA Nixes Medical Device Data Systems Enforcement
Makers of software that passively stores, transfers, formats or displays medical device data no longer need to worry about the quality system regulation or other basic device requirements for the products, according to a June 20 draft guidance.
Health IT Deregulation Bill Introduced In Senate, With Powerful Industry Backers
The PROTECT Act, which attempts to respond to some criticisms of the House SOFTWARE Act, aims to restrict FDA’s oversight of health information technology. It is backed by IBM and Verizon, among others.