Request for Comments on Risk-Based Regulatory Framework for Health IT
PattonBoggs.com Health Care Client Alert 1JUNE 18, 2013This Alert provides only generalinformation and should not berelied upon as legal advice. ThisAlert may be considered attorneyadvertising under court and barrules in certain jurisdictions.For more information, contact yourPatton Boggs LLP attorney or theauthors listed below.PAUL BESOZZIpbesozzi@pattonboggs.com202.457.5292MELODI GATESmgates@pattonboggs.com303.894.6111MARTIE KENDRICKmkendrick@pattonboggs.com202.457.6520KAREN SMITH THIELkthiel@pattonboggs.com202.457.5229ABU DHABIANCHORAGEDALLASDENVERDOHADUBAINEW JERSEYNEW YORKRIYADHWASHINGTON DCHEALTH CARE CLIENT ALERTREQUEST FOR COMMENTS ON RISK-BASED REGULATORY FRAMEWORK FORHEALTH ITAn interagency working group – composed of the Food and Drug Administration(FDA), Office of the National Coordinator for Health Information Technology(ONC), and the Federal Communications Commission (FCC) – is seeking publiccomment on elements that should be considered in developing a risk-basedregulatory framework for health information technology (IT), which promotesinnovation, protects patient safety, and avoids regulatory duplication. This effortis the outgrowth of several regulatory developments regarding mobile medicalapplications and health IT in general.Health IT significantly assists providers in clinical decision-making and empowerspatients to make informed decisions that improve the quality of their lives.Equally, health IT has the potential to cause harm to patients if it is not properlydesigned, developed, implemented or used. In July 2011, FDA issued draftguidance, indicating its intent to regulate a subset of mobile medical applicationsas medical devices under the Federal Food, Drug, and Cosmetic Act (FFDCA).Recognizing the importance of a coordinated regulatory approach, Congresstasked FDA, ONC, and FCC with developing a proposed risk-based regulatoryframework for health IT. The agencies formed the Food and DrugAdministration Safety and Innovation Act (FDASIA) Workgroup to provide inputand recommendations on issues relevant to developing a health IT regulatoryframework.In February, the Bipartisan Policy Center (BPC) released its recommendations fora risk-based regulatory framework specific to health IT. BPC emphasized thatFDA’s current regulatory approach for medical devices is not well-suited forhealth IT. Unlike medical devices, in which safety is largely dependent onmanufacturing, safety in health IT requires a shared responsibility amongdesigners, developers, implementers, and users. BPC’s recommendations received
PattonBoggs.com Health Care Client Alert 2endorsements in March by health care industry representatives during a series of three House Energy and Commerce(E&C) Committee hearings on health IT.FDA, ONC, FCC, and the FDASIA Workgroup seek broad public comment on the following topics:→ Taxonomy. What types of health IT should be addressed by the report developed by FDA, ONC, and FCC?→ Risk and Innovation. What are the risks to patient safety posed by health IT and what is the likelihood ofthese risks? What factors or approaches could be included in a risk-based regulatory approach for health IT topromote innovation and protect patient safety?→ Regulation. Are there current areas of regulatory overlap among FDA, ONC, and/or FCC, and if so, whatare they? Please be specific if possible. If there are areas of regulatory overlap, what, if any, actions should theagencies take to minimize this overlap? How can further duplication be avoided?Comments may be submitted electronically (http://www.regulations.gov , ID: HHS-OS-2013-0003-0001)until 11:59 p.m. Eastern Time, August 31, 2013. Comments submitted by June 30, 2013 will be considered bythe FDASIA Workgroup, who will make recommendations to FDA, ONC, and FCC.For assistance in preparing your comments or additional background on the request for comments, please contactPaul Besozzi, Mel Gates, Martie Kendrick, or Karen Thiel.