EHCI Policy Topics (Draft March 20 2013)




1.  Office of mHealth FDA There may be broad agreement that more focus on mobile health is justified but differing opinions about whether this should be within or outside FDA and if within FDA as an office or a function.  HR 6626 introduced; MRC Coalition.  Note activity lead by the House Energy & Commerce Committee.
2.  Intended Use Clarification FDA Key question – can manufacturers avoid device regulation for consumer devices through its intended use and marketing plans? MRC and CDS Coalitions; House E&C Committee in the mix.
3.  Accessory Rule FDA Key question – when are consumer communication devices a regulated accessory to a medical device?  MRC and CDS Coalitions.
4.  Software Modularization FDA Can we define a simpler approach to medical software regulation? MRC and CDS Coalitions.
5.  Mobile PERS FDA To be defined
6.  Reimbursement for mobile/telehealth HHS


Additional FFS generally not favored by CMS. HR 6719 introduced.  ATA is logical collaborator.
7.  Privacy & Security HHS, ONC Increasing attention by stakeholders
8.  Meaningful use and mobile health CMS, ONC Meaningful use guidelines under development
9.  Randomized Clinical Trial (RCT) improvement FDA RCT is the “gold standard” for establishing the safety and efficacy of medical devices and drugs.  These are expensive, time consuming and not effective at identifying all potential adverse effects.  In addition, promising drugs are kept off the market for long periods of study and when an unidentified risk is subsequently discovered, FDA’s response is often to remove a drug form the market for all uses even if it is safe for some uses or patients.  Personnel in key government agencies acknowledge this problem.  Mobile/connected health technologies have the potential to streamline and improve the documentation of trials and industry is pursuing these documentation strategies.  Much more significantly, by the application of after-market surveillance, powered by connected health, we can speed promising devices and drugs to market, deliver real time results, and modify labeling and indications for use based on these real world results.
10.  Reduce state impediments to HC systems CONG 50 state regulation of insurance and providers creates anti-competitive barriers and impediments to nation-wide systems for all health care services including telehealth
11.  Wireless health standards & protocols FCC, INDUSTRY Spectrum interference creates operating issues and uncertainty about levels of service especially in institutional settings.   FCC has recently promulgated a rule for Body Area Networks.  Private initiatives are being considered by several organizations.
12.  FCC/FDA Task Force FCC/FDA The MOU issued in 2010 contained hopeful language but minimal significant follow-though.  Key question is whether FDA can recognize FCC leadership on certain issues.
13.  Medical Device Tax CONG This excise tax was adopted as part of the funding mechanism for PPACA following a breakdown in negotiations between the White House and the medical device industry.  Extremely unlikely to be repealed but as an excise affecting companies of all sizes and profitability it poses significant problems for early stage companies. There is some bipartisan support to address this issue.
14.  FCC Broadband Plan (HC Chapter) FCC Likelihood to be defined
15.  Access to Capital SEC, CONG First priority is to compete regulations to implement the JOBS Act
16.  Section 618 FDA Safety & innovation Act HHS, FDA, FCC, ONC Opportunity to promote regulatory coordination. MRC.