The FDA released a draft guidance on how it will regulate mobile and wireless healthcare devices and applications, which to a large extent follows proposed guidance from the mHealth Regulatory Coalition. The guidance may facilitate growth of this industry segment.
Our Ides of March Potpourri, featuring two studies of the impact of wellness programs; the link between hospital spending and mortality outcomes; HHS waiving the MLR requirement for Maine; bills to have CMS disclose physician practice patterns; and research on smoking cessation techniques.
An incredibly useful paper has been issued by the mHealth Regulatory Coalition on issues surrounding potential FDA regulation of communications technology used for health-related purposes. The paper provides background and a discussion of the significant issues upon which the industry, patients and providers need guidance.
On the menu for this week’s potpourri–savings from wellness efforts for a large employer; drug reimbursement for Medicaid programs; using remote monitoring in a health plan context; the FDA’s regulatory approach to mobile health uses; the effect of tort reform on imaging rates and hepatitis C pay-for-performance measures.