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mhealth IT Oversight: Stability Will Come from Clarity, Not Rush

by Dan Haley, SVP and General Counsel

In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”). The Agency solicited and received public comment. Thereafter began a nearly two-year waiting game that continues to this day and has more than a few mhealth stakeholders clamoring for final guidance to provide “clarity” and, by extension, confidence to potential mhealth investors waiting impatiently on the sidelines.

A lot has happened in those many intervening months. For one thing, the once-rational distinction between “mobile” information technology and everything else has become less and less connected to the reality of the technological world that we live in. Put another way, all communications technology is now “mobile” to one degree or another.

More importantly, in July of last year, via FDA Safety and Innovation Act (“FDASIA”) Congress instructed the Obama Administration to recommend a “risk-based” framework for oversight of health IT with three clearly-stated objectives: (1) to protect patients; (2) to promote innovation; and (3) to avoid unnecessary regulatory duplication. Crucially, Congress explicitly included mhealthIT in its FDASIA mandate.

In April 2013, Health and Human Services (HHS) Secretary Sebelius convened a stakeholder workgroup (the “FDASIA Workgroup”) to inform that recommended framework. The FDASIA Workgroup has solicited public comment, held meetings on a more-than-weekly basis, and is on track to issue its recommendations in August.

Some industry stakeholders have urged the FDA to release its final Mobile Guidance as quickly as possible, despite the clear, intervening Congressional call for a comprehensive framework. Others (including athenahealth) disagree emphatically. That’s why in June we helped to pull together a broad coalition of more than 140 healthcare stakeholders, including nearly two dozen consumer groups, 18 medical societies and physician groups, six hospitals, 75 health IT start-ups, and dozens of other potentially-impacted entities and groups. That coalition sent a letter (reproduced below) to key Administration figures, including Secretary Sebelius, asking FDA to hold off on issuing final Mobile Guidance until the FDASIA Workgroup has provided its Congressionally-mandated recommendations and the Administration has crafted the required comprehensive oversight framework. Emphasizing Congress’s clearly-expressed instruction that HHS should avoid unnecessary regulatory duplication, the coalition letter argued that final Mobile Guidance issued before release of the FDASIA-required recommendations for a comprehensive oversight framework, encompassing mhealth IT, would increase rather than alleviate uncertainty in the mhealth marketplace.

This is very much a live issue in Washington this month, with the FDASIA workgroup preparing to issue its recommendations, rumors persisting about potential final mobile guidance from FDA, and continued uncertainty about the prospects for and the final form of the Congressionally-mandated comprehensive oversight framework. We continue to believe that true regulatory certainty will be provided not by regulatory haste, but by careful deliberation to produce a clear, non-duplicative, risk-based approach that protects patients while fostering innovation. Congress clearly mandated such a framework. The Administration should honor that mandate and resist well-intentioned but ultimately counter-productive calls for rushed, piecemeal regulation.


Coalition Letter

Health Information Technology Framework

June 18, 2013

The Honorable Kathleen Sebelius
Secretary
Department of Health and Human Services
200 Independence Avenue, S.W., Room 445-G
Washington, DC 20201

The Honorable Mignon Clyburn
Acting Chairwoman
Federal Communications Commission
445 12th Street, SW
Washington, DC 20554

Margaret A. Hamburg, MD
Commissioner
Food and Drug Administration
Department of Health and Human Services
10903 New Hampshire Avenue
Silver Spring, MD 20903
Farzad Mostashari, MD, ScM
National Coordinator for Health Information Technology
Department of Health and Human Services
200 Independence Avenue, SW., Room 729D
Washington, DC 20201

As health care leaders, we appreciate the Administration’s recognition of the important role that health information technology (IT) plays in improving health and health care and share your view that broad adoption is critical to the success of payment and delivery reforms. We are actively engaged in the transformation of health care from a system burdened by paper to one empowered by interoperable electronic solutions that improve patient safety, reduce the cost and variability of care, and advance health care efficiency and quality. While proper oversight of health IT is critical to ensuring patient safety, such oversight must be implemented in a balanced way that also fosters innovation and encourages adoption of these technologies.

We commend the Administration for recently launching a Workgroup in response to the Food and Drug Administration Safety Innovation Act (FDASIA) of 2012, which calls for the Secretary of Health and Human Services (HHS) to work with the Food and Drug Administration (FDA) Commissioner, the National Coordinator for Health IT, and the Chairman of the Federal Communications Commission (FCC) to post a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication. The thoughtful, comprehensive, and inclusive approach being taken by the Administration to inform Congress will be critical as it develops this new regulatory framework for health IT.

To that end, we urge the Administration to allow ample time for the FDASIA Workgroup to complete its work and to take into consideration the Administration’s final recommendations on a risk-based regulatory framework pertaining to health IT in any future Agency guidance or policy to be released associated with the regulation or oversight of health IT.

June 18, 2013
Page two

We further encourage the Administration to consider any Congressional recommendations on a risk-based regulatory framework that emerge following the publication of the Administration’s final report and to work with Congress on the development of appropriate oversight mechanisms for health IT, including mobile applications. Congress may also choose to pursue revisions to Section 201(h) of The Food, Drug and Cosmetic Act, as amended in 1976, to reflect the explosive growth in and rapidly evolving nature of information technology in health care. We believe that, by working collaboratively, Congress and the Administration can produce a statutory framework for regulation of health IT based on risk while supporting innovation and patient safety.

We look forward to continuing to work with the Administration as well as Congress to ensure that health IT is regulated in a way that achieves the goals of improving the quality, safety and cost-effectiveness of care.

Sincerely,

1DocWay
ABW Medical
Advanced Heart Care
Alliance for Quality Improvement and Patient Safety
ALS Association
American College of Emergency Physicians
American Society of Clinical Oncology
American Association of Diabetes Educators
American College of Physician Executives
American Medical Group Association
American Medical Informatics Association
American Nurses Association
American Osteopathic Association
Ascension Health
Association of Medical Directors of Information Systems
athenahealth
AwarePoint Corporation
AZZLY
BetterFit Technologies
BIO-Key International
Bio-Reference Laboratories, Inc.
Blisstering Solution
Carman Nan, MD
Center for Democracy and Technology
Chaos Health
Coalition of Heritable Disorders of Connective Tissue

June 18, 2013
Page three

College of Health Information Management Executives (CHIME)
ConversePoint
CPSI
CRG Medical, Inc.
Dell Inc.
DICOM Grid, Inc.
DualAlign LLC
DxID
eCardio
eHealth Technologies
e-MDs
Empower Interactive, Inc.
Entrada
Epion Health
Epocrates
eVariant, Inc.
Evergreen Family Medicine
EW Consulting, Inc.
Eye Center of La Jolla
FlexLife Health
Flor J. Caballar Gonzaga, MD, FAAP
FoodCare Inc.
Frontier Neurosciences
Genelex Corp.
Genetic Alliance
Get Real Health
Greenway Medical
Greenwings Biomedical
Health Care Service Corp.
Healthcare Leadership Council
HealthPost, Inc.
Health Fidelity
HealthFortis
Health Options Worldwide
Hermes Clinical
Hernando County Medical Society
HLM Venture Partners
IMPACTMeds
Intel Corporation
InteliChart
Intermountain Healthcare
INUVIO, Inc.

June 18, 2013
Page four

Kareo
Keona Health
Leukemia and Lymphoma Society
M3 Information
Madaket Health
Martin, Blanck and Associates
Matrix Partners
McKesson Corporation
MedicalRecords.com
MemorialCare Health System
Metro Atlanta Chamber of Commerce
Microsoft
Modernizing Medicine
Monebo Technologies
MyhealthEcare
National Association of Manufacturers
National Health IT Collaborative for the Underserved
National Patient Safety Foundation
Navigating Cancer
National Retail Federation
NextGxDx
New Capital Partners
New York eHealth Collaborative
Newborn Coalition
Northern Cambria Medical Center
Oracle Corporation
OZ Systems
Patient Conversation Media
Pharmacy e-Health Information Technology Collaborative
pMD
Polyglot Systems, Inc.
Pristine
PXE International
Quality Systems Inc./NextGen Healthcare
QPID, Inc.
Radisphere
RazorInsights
Ringful Health LLC
Seamless Medical
Sharp HealthCare
Siemens Corporation
Silicon Valley Chapter of Health 2.0

June 18, 2013
Page five

Simple Health Ventures Inc.
South Denver Obstetrics and Gynecology PC
StartUp Health
Syapse
Teladoc Inc.
TeleCare Global
TenacityHealth
Texas e-Health Alliance
Tidepool
U.S. Chamber of Commerce
U.S. Oncology Network
UnitedHealth Group
Vieu Health
Visual Health Solutions, Inc.
VitalWare, LLC
WelVU

Copies:
Chris Dawe, Policy Advisor for Healthcare, National Economic Council, Executive Office of the President
Jeanne Lambrew, Deputy Assistant to the President for Health Policy, Office of Health Reform, Office of White House Policy, Executive Office of the President
Todd Park, U.S. Chief Technology Officer and Assistant to the President, Office of the Chief Technology Officer, Office of Science and Technology Policy, Executive Office of the President

Addendum to Letter Dated June 18, 2013
As of August 1, 2013

Additional Organizations Who Signed on to the Letter After June 18, 2013:

American Academy of Family Physicians
American Academy of Pediatrics
ECRI Institute
Erik Metzler Foundation
EveryLife Foundation for Rare Diseases
Health Level 7 International
HP
Idiopathic Pulmonary Hemosiderosis, IPH-NET
Jonah's Just Begun-Foundation to Cure Sanfilippo Inc.
Little Miss Hannah Foundation
Mastocytosis Society
MLD Foundation
National Tay-Sachs & Allied Diseases Association, Inc.
NexTech
Patient-Centered Primary Care Collaborative
Sanfilippo Foundation for Children (SF4K)
Suncoast Solutions

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