8th Annual Virginia HIMSS Day at the General Assembly

January 16, 2014

David Collins, MHA, CPHIMS, FHIMSSSenior Director, HIMSS

mHealth: The Balance of Patient Safety & Innovation

Agenda

Importance of Mobile Technology and mHealth:

• HIMSS Mobile Initiative

• A quick snapshot at the State, Federal, & Congressional levels

• Highlights of the FDA’s Mobile Medical App Guidance

• Highlights of the FDA Safety & Innovation Act of 2012

• HIMSS Mobile Resources & Upcoming Events

mHIMSS at a glance

• Launched December 2011

• HIMSS mHealth Community

• Corporate membership

• Non-profit partnerships

• Advisory Council, taskforce, and workgroups

• Resources @ www.himss.org/mobilehealthit

• Largest global mHealth event www.mhealthsummit.org

• LinkedIn & Twitter

• Annual healthcare delivery mobile survey powered by HIMSS Analytics

• Strategic framework for mHealth implementation, case studies, other

A Strategic Framework for Hospitals and Health Systems Present and Future State of

mHealth

New Care ModelsTechnology

ROI and PaymentsPolicy

Privacy and SecurityStandards and Interoperability

www.himss.org/mobilehealthit/roadmap

Why Mobile?

• The mobile health market, is expected to reach $26 billion by 2017, according to 2013 report, Mobile Health Trends and Figures 2013-2017, from Research and Markets.1

• A June 2013 Nielsen report indicated 3 out of 5 U.S. mobile subscribers, or more than 60 percent, own a smartphone, which is comparable to having an internet-enabled computer in their pocket. 2

• According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications.3

• Today, mobile devices are more powerful than ever before. A typical smartphone has more computing power than Apollo 11 did when it landed on the moon.4

State Policy Issues

• Bills potentially impacting health IT and mobile health in more then 50% of the States

• Privacy & Security– Clear, accurate, and conspicuously accessible privacy policies for

users / potential users

• Telehealth/Licensure

• Paying for care provided via mobile, & ROI of mobile

• Breach Notifications– Legislation setting forth when notifications must be published,

and how to conduct a notification

• Cybercrime– State wiretapping legislation and misappropriation of trade

secrets legislation

Congressional Landscape

• 112th and 113th Congress: 17 bills introduced

• Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012

Federal Departments & Agencies• HHS publishing FDASIA report 1st quarter 2014: a regulatory framework for health IT

and mobile

– FDA, ONC, & FCC part of FDASIA report creation

• Mobile as a topic within ONC’s Policy and Standards Committees

• FDA published guidance on mobile medical apps – September 2013

• NIST released a draft Cybersecurity Framework

• FCC addressing MBAN (mobile body area network) and other spectrum allocation issues; Hosted inaugural FCC mHealth Forum – December 2013

• FTC seeking input on the “Internet of Things” (everyday devices that communicate w/each other and w/humans)

Resources

Federal & State mHealth Legislation –

mHIMSS Environmental Scan

• mHealth environmental scan of policy at the Federal and State levels.

• The intent of this resource is to provide a snapshot in time of mHealth related topics that are under review, or that have been considered for legislation (which will provide context for how a topic has evolved over time).

www.himss.org/mobilehealthit

Resources

Mobile Health IT in the States:

A Policy Perspective using the mHIMSS Roadmap

• This document presents a framework for analyzing a number of key issues emerging in the mHealth space.

• The document also serves as a guide for healthcare providers to further adopt mobile and wireless technology.

• The document contains four separate sections focused on: Technology/New Care Models, Telemedicine/Licensure, Standards & Interoperability/Privacy & Security, and Payment/ROI.

• The framework of the document will be leveraged to assess emerging issues related to state policy.

www.himss.org/mobilehealthit

FDA Mobile Medical App Guidance

“This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations…”

Purpose of the guidance:

• FDA’s intentions to

– Exercise its authority over a subset of mobile apps

– To promote innovation

– To protect patient safety

It’s not about the platform, it’s about the functionality

• In general, if a mobile app is intended for use in performing a medical device function, FDA will continue to regulate that function, regardless of the platform on which it is run

• The regulatory requirements manufacturers must meet are determined by the intended use of the mobile medical app

• FDA only intends to apply oversight authority to those mobile apps whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended

Three Key Concepts

1. Appendix A - “Not regulated” means mobile apps that are not considered medical devices under the FDA regulations

– Mobile apps that are intended for health care providers to use as educational tools for medical training or to reinforce training previously received.

2. Appendix B - “Enforcement discretion” means FDA’s decision not to enforce requirements under the Food, Drug, and Cosmetics Act (FD&C Act) on mobile apps that are medical devices, but pose a low risk to patients

– Mobile apps that use video and video games to motivate patients to do their physical therapy exercises at home

3. Appendix C - “Regulated” means mobile apps that are considered medical devices under the FDA regulations (i.e., “mobile medical apps”)

– Mobile apps that use a sensor or lead that is connected to a mobile platform to measure and display the electrical signal produced by the heart (electrocardiograph or ECG).

Mobile Medical App Manufacturer

• Regardless of regulatory oversight, manufacturers are encouraged to follow the Quality Systems regulations to prevent harm in the development of all mobile apps

Scope of the FDA MMA Guidance

• The “Scope” of the mobile medical apps guidance does not address

– Patient specific analysis to aid or support clinical decision making (CDS)

– Accessories

FDASIA: Food & Drug Administration Safety & Innovation Act

• Workgroup: Provide expert input to the FDA, ONC, and FCC

• To help inform the development of a report on “an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications (MMA) that promotes innovation, protects patient safety, and avoids regulatory duplication”

“Within current regulatory frameworks there exist mechanisms that the Food and Drug Administration (FDA), the ONC, and the Federal Communications Commission (FCC) could use to promote innovation, protect patient safety and avoid regulatory duplication (and cost). New frameworks aimed at stimulating innovation may be helpful as well.”

Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012

• Gives FDA authority to collect user fees to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biological products;

• Promotes innovation to speed patient access to safe and effective products;

• Increases stakeholder involvement in FDA processes;

• Enhances the safety of the supply chain.

• Jan, 2014 - requires report to Congress on a risk-based regulatory framework for regulating Health IT

FDASIA: Timeline for Action

• May 2013: HIT Policy Committee creates Workgroup

• July 2013: HIMSS responds to FDASIA Workgroup request for public comment on certain categories

• *September 4th: HIT Policy Committee submits approved recommendations to FDA, FCC, and ONC

• September 2013 to January 2014: FDA, FCC, and ONC reviewing and making recommendations to HHS Secretary

• January 2014: Draft Report to Congress due from HHS

• January/February 2014: Public Comment period for Draft Report and Framework

HIMSS RecommendationsSubmitted letter to HHS in November 2013

• Support a risk-based regulatory framework for health IT solutions that would not be subject to FDA’s current Regulatory Framework

• HHS establishes a new regulatory framework recognizing the unique and unprecedented capabilities of health IT products that are not appropriate for categorization within existing medical device framework

• Health IT products be classified within a parallel risk-based framework by intended use and capabilities

• Manufacturer responsibility for products extend to the point in which the manufacturer has control over the product; end-users responsible for customized products

What’s Next?• FDASIA Report to Congress – February or March

• SOFTWare Act or similar proposed legislation

Opportunities, Upcoming Events, & Resources

3rd Annual Mobile Surveywww.himss.org/mobilehealthit/survey

Complete the HIMSS 3rd Annual Mobile Survey and receive a $25 registration credit for the 2014 mHealth Summit

For the first time in 2011, HIMSS Analytics explored the use of mobile technology to improve access to the information needed on a day-to-day basis in a healthcare setting. The study was designed to collect information on an array of items related to mobile device usage. Questions assess organizations’ general use of mobile technology, access to patient data, means for securing information, and the benefits and barriers around the use of mobile technology.

This year’s survey is built around the six topics of the mHIMSS Roadmap: New Care Models, Technology, ROI/Payment, Legal/Policy, Standards & Interoperability, and Privacy & Security.

As a thank you for participating, the first 200 respondents working for a provider organization to complete the entire survey will receive $25 off their 2014 mHealth Summit registration. Additionally, all respondents have the option of being entered to win a 32GB Tablet!

Complete the survey by January 17, 2014

Watch for the Mobile Technology Survey Results to be released at HIMSS14 in Orlando.

Upcoming Events• mHIMSS Open Mic: Fri, January 24 @ 1pET: ROI and mHealth

• Mobile Medical App Roadshows

– January 16 – University of IL

– January 23 – Johns Hopkins

– January 27 – University of California San Diego

– January 28 – Stanford University

– January 31 – University of Texas at Austin

– March 20 – MIT

– May 8 – mHealth Summit Europe

– June 13 – HIMSS Innovation Center, Cleveland

– MRC Website – Event Announcement (w/ link to registration)

» http://mhealthregulatorycoalition.org/events/

•  

– Direct link to Registration:

» MMA Roadshow Registration

HIMSS14: www.himssconference.org

Feb 23 – 27, Orlando

• Mobile & HIMSS14 - General Education Sessions

• HIMSS14 Mobile Health Symposium

• mHealth – Policy, Technology, & Innovation: Striking the Balance for Mobile SuccessSunday, 2/23, 8:30am - 4:30pm , Room 307A-B

•  Mobile Knowledge Center

– Mon – Wed, 2/24-2/26 - [Exhibit Floor] Hall E 7745

• 20 mHealth Exhibitors & Theatre presentations

– Results of the 3rd Annual HIMSS Analytics/mHIMSS Mobile Survey

HIMSS Mobile Resources

• mHIMSS Summary and Analysis FDA Mobile Medical Applications Final Guidance

• mHIMSS Roadmap: Mobile Health Apps: A Practical Guide for Healthcare Stakeholders

• Mobile Security Toolkit

• Use Case Study: Christus Health - Improving Health at Home: Remote Patient Monitoring and Chronic Disease

• Apps to Aid Healthcare Delivery in Disparate Communities: A Guide from mHIMSS

References

• FDA: Food & Drug Administration

– Mobile Medical Guidance

– mHIMSS Summary & Analysis

• FDASIA: Food & Drug Administration Safety & Innovation Act - Committee Report

• FCC: Federal Communications Commission

– www.fcc.gov/health

References

• FTC: Federal Trade Commission

– Mobile Privacy Disclosures: Building Trust Through Transparency

• NIST: National Institutes for Standards & Technology

– NIST Cybersecurity Framework

David Collins, MHA, CPHQ, CPHIMS, FHIMSS

mHIMSS, Senior Director

dcollins@himss.org

+01 804 310 0615

@collinsdavid

www.himss.org/mobilehealthit

Thank you!

FDASIA Detailed Overview

Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012

• Gives FDA authority to collect user fees to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biological products;

• Promotes innovation to speed patient access to safe and effective products;

• Increases stakeholder involvement in FDA processes;

• Enhances the safety of the supply chain.

• Jan, 2014 - requires report to Congress on a risk-based regulatory framework for regulating Health IT

FDASIA: Timeline for Action

• May 2013: HIT Policy Committee creates Workgroup

• July 2013: HIMSS responds to FDASIA Workgroup request for public comment on certain categories

• *September 4th: HIT Policy Committee submits approved recommendations to FDA, FCC, and ONC

• September 2013 to January 2014: FDA, FCC, and ONC reviewing and making recommendations to HHS Secretary

• January 2014: Draft Report to Congress due from HHS

• January/February 2014: Public Comment period for Draft Report and Framework

FDASIA Workgroup Recommendations

Leveraged “Eight Key Dimensions of HIT”  

– Intended use

– Conditions of use

– User type

– Developer/ ‘Manufacturer’ type

– Distribution model

– Phase of the product lifecycle

– Product categories

– Other

FDASIA Workgroup Recommendations

Definition that would possibly be subject to a risk-based regulatory framework:

• EHRs (installed, SaaS)

• Hospital information systems-of-systems

• Decision support algorithms

• Visualization tools for anatomic, tissue images, medical imaging and waveforms

• Health information exchange software

• Electronic/robotic patient care assistants

• Templating software tools for digital image surgical planning

• Products such as types of CDS or medical device accessories.

FDASIA Workgroup Recommendations

• Used patient-safety risk framework and examples as building blocks to develop a more robust and transparent framework

– allow application of oversight by level of risk

• Substantial additional regulation of HIT beyond what is currently in place is not needed, except for:

– Medical device data systems (MDDS)

– Medical device accessories

– Certain forms of high risk clinical decision support

– Higher risk software use cases

• Definition of what is included in HIT should be broad but have also described exclusions

Framework for a HIMSS Position

• Submitted letter to HHS in November 2013

• Framework

– Focus on four areas:

• A Holistic Approach

• Shared Responsibility

• Clear Oversight Direction

• Role of Intended Use/Functionality

Holistic Approach

• Recognize that health IT is part of a complex patient care ecosystem.

• HHS should establish a new regulatory framework recognizing the unique and unprecedented capabilities of health IT products that are not addressed by, would not fit into, and are not appropriate for categorization within the existing medical device framework.

• Health IT’s complex and evolving role in the patient care ecosystem warrants an updated framework to provide clarity and predictability.

Shared Responsibility

• The safety and efficacy of health IT can be enhanced through non-punitive surveillance and reporting systems.

• Health IT must be considered a part of a broader patient care system, and all stakeholders must be able to participate in surveillance and reporting activities.

Clear Oversight Direction

• Clear and consistent guidance is essential to ensure that health IT can continue to provide the innovation and tools necessary to achieve the patient safety goals and cost efficiencies sought by all stakeholders.

• FDA’s recently-issued mobile medical device app guidance is a good example of enforcement discretion

Role of Intended Use/Functionality

• Regulation and oversight actions should be based on the intended purpose and intended user of a particular product or service.

• A manufacturer’s primary responsibility for a product extend to the point in which the manufacturer has control over the product.

Risk-Based Framework Components

• Balance the costs and benefits of any program proposal;

• Ensure clear, consistent and non-duplicative language and enforcement;

• Be affordable to those expected to bear direct and indirect compliance costs;

• Avoid adding burdens that inhibit or delay improvements to systems that improve care delivery and safety;

• Work in concert with the medical device regulation framework; and,

• Remove existing health IT that is primarily administrative or financial software from consideration from either the risk-based or medical device regulatory frameworks.

HIMSS RecommendationsSubmitted letter to HHS in November 2013

• Support a risk-based regulatory framework for health IT solutions that would not be subject to FDA’s current Regulatory Framework

• HHS establishes a new regulatory framework recognizing the unique and unprecedented capabilities of health IT products that are not appropriate for categorization within existing medical device framework

• Health IT products be classified within a parallel risk-based framework by intended use and capabilities

• Manufacturer responsibility for products extend to the point in which the manufacturer has control over the product; end-users responsible for customized products