An Update on the Activities and Progress of the mhealth Regulatory Coalition Prepared for the 2011 Medical Device Connectivity Conference

Transcription

1 An Update on the Activities and Progress of the mhealth Regulatory Coalition Prepared for the 2011 Medical Device Connectivity Conference Dane Stout The Anson Group September 8, 2011

2 MRC Background Formed July 2010 to proactively address regulatory policy impediments to mhealth Broad based industry coalition open to all stakeholders who have an interest in the use of mobile health Single issue focus, not another industry consortium Collaborative and cooperative approach to working with FDA All work made publicly available at web site

3 A Pragmatic roach Three Primary Ways for Regulatory Policy Change to Occur 1. New Legislation 2. Rule making under existing law 3. Guidance document publications Changing laws or publishing new rules in the Federal Register can take years Guidance is fastest path to provide clarity industry needs for investment decisions MRC Charter: develop reasonable guidance for mhealth technologies in one year

4 Progress to Date December 2010 Published Whitepaper mhealth definition and Problem Statement Focus on 3 Key FDA Regulatory Obstacles for mhealth Intended Use Claims Accessory Rule Standalone Software (FDA definition) Invested 2011 on draft guidance development Publish consolidated document by 12/11 Submit to FDA according to Good Guidance Practice rules in 21CFR

5 MRC Current Active Membership Agamatrix Aging Technology Alliance AT&T Boston Scientific Center for Connected Health Continua Alliance Extension, Inc. Fio Corp. Ideal Life Online Jitterbug Kaiser-Permanente Meds MedicalGraphics Nokia Philips Healthcare Qualcomm RCRI Roche Tech America Foundation WellDoc, Inc. Zoll Medical

6 mhealth Regulatory Coalition (MRC) Manufacturers & Distributors Non-profit organizations mhealth Regulatory Coalition Healthcare Providers What will FDA regulate? In what device class?

7 The MRC Guidance Document Intended Use Claims Accessories & Claims of Compatibility Software s

8 Part 1: Intended Use Claims

9 Importance of Intended Use Claims Intended use determines whether a product meets the definition of a device, shown by: Labeling claims Advertising materials Oral or written statements A product is a device if it is intended: For use in the diagnosis, cure, mitigation, treatment, or prevention of disease; or To affect the structure or any function of the body of man.

10 Importance of Intended Use Claims Statements Suggesting Popsicle Stick It s a popsicle stick Sterilized to food grade Kids love it Makes popsicles last longer Statements Suggesting Pediatric Tongue Depressor It s a Pediatric Tongue Depressor Sterilized to medical grade Young patients love it Narrow enough to access those hard to reach places in a kid s mouth Tastes Great

11 Intended Use Claims in mhealth Within FDA Jurisdiction Medical Devices A. Socially Beneficial, Low Risk Devices Uncertain Jurisdiction B. Ambiguously Defined, Low Risk Products Outside FDA Jurisdiction Consumer Products Disease related claims that clearly constitute device claims. Wellness related claims that could constitute device claims, but should not be regulated to encourage development. Disease/wellness related claims that might constitute device claims, but it is unclear. Wellness related claims that clearly do not constitute device claims.

12 MRC s roach Socially Beneficial, Low Risk Device Exemption Reduce the risk of Improve or Maintain Impact Claims Information Flow Claims Collect or Aggregate Exemption based on the use of generally recognized health claims. Capture or Detect Alert or Notify

13 MRC s roach Ambiguously Defined, Low Risk Product Exclusion Non- Diagnosis/ Prevention/ Treatment Non-Disease Outside the definition of a medical device.

14 MRC s roach Language Ambiguity Inherent Product Risk Regulatory Decision Likelihood of an Adverse Event Severity of Harm

15 MRC Comparison to FDA roach Similarities Intended use determines device status. Differences FDA approach is broad and can result in overregulation. MRC approach focuses regulation on moderate- to high-risk devices, exempting or excluding low-risk products.

16 Part 2: mhealth Accessories

17 Traditional Accessory roach

18 MRC s roach

19 MRC s roach Create an independent classification applicable to the accessory Require claims of compatibility to be substantiated by the claim maker

20 MRC vs. FDA roach Similarities Interactions between devices and non-device products must be validated by the claim maker. Differences MRC approach does not require up-regulation of traditional accessory products. MRC approach requires creation of mhealth classification regulations. Avoids unnecessary and untenable regulation of enabling mobile infrastructure and technology

21 Part 3: mhealth Software

22 FDA s MDDS Rule Electronic Storage Electronic Conversion Medical Device Data Electronic Transfer Electronic Display Active Patient Monitoring

23 Mobile Medical s Guidance Medical Device Intended Use Accessory to a Regulated Device OR Transforms a Mobile Platform Mobile Medical s that connect to one or more medical device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data. s that transform the mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Algorithms that output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice

24 Mobile Medical s Guidance Medical Device Intended Use Accessory to a Regulated Device OR Transforms a Mobile Platform Mobile Medical Electronic copies of medical textbooks, teaching aids or reference materials s solely used to provide clinicians with training or reinforce training previously received s solely used to log, record, track, evaluate, or make decisions related to developing or maintaining general health and wellness s that only automate general office operations with functionalities Generic aids that assist users but are not commercially marketed for a specific medical indication

25 Mobile Medical s Guidance Medical Device Intended Use Accessory to a Regulated Device OR Transforms a Mobile Platform Mobile Medical Electronic health record system or personal health record system (Don t misinterpret this that FDA won t regulate these)??? s that automate common medical knowledge available in the medical literature s that allow individuals to self-manage their disease or condition s that automate common clinician s diagnostic and treatment tasks using simple general purpose tools

26 Future FDA Guidance on mhealth Mobile Medical s Accessory Rule? FDA is seeking comment on how it should approach mobile medical apps that are accessories to other medical devices. Future FDA Guidance Wireless safety considerations Classification and submission requirements related to clinical decision support software The application of quality systems to software Home Use

27 Proposed Classification Regulations MDDS Physical Therapy Sleep Monitoring Stress Mgmt. Weight Mgmt. Diabetes Cardiac Disease Therapy Compliance Activity Monitoring Class I Controller Class II/III Controller General Aggregator Diabetes Aggregator Cardiac Aggregator Therapy Aggregator Activity Aggregator

28 Software Modularization Use of standard design principles creates functional independence and reduces inherent risk of discrete modules.

29 Evolution of Technology New technology fits within the classification and any associated exemptions. Reasonably foreseeable at the time the classification was created. No significant new risks created by the technological advances.

30 MRC vs. FDA roach Similarities s are regulated under applicable classification regulations. General health and wellness apps, EHRs/PHRs, and general teaching aids are not regulated. Differences FDA approach relies on traditional accessory rule. MRC approach relies on regulatory classifications for individual products, standard design principles for modularization, and claim substantiation.

31 Part 4: Other Relevant Regulations highlighted in MMA Guidance Draft

32 FDA s Definition of a Manufacturer Medical Device Manufacturer Mobile Medical Manufacturer Anyone who initiates specifications, designs, labels, or creates a software system or application in whole or from multiple software components. Excludes entities that exclusively distribute mobile medical apps, without engaging in manufacturing functions. Mobile Platform Manufacturer Anyone who commercially markets a mobile platform with an intended use of, or to be used with, a device. Excludes entities that solely distribute or market its platform with no device intended use.

33 MRC s roach Medical Device Manufacturer Mobile Medical Manufacturer Anyone who initiates specifications, designs, labels, or creates a software system or application in whole or from multiple software components. Excludes entities that exclusively distribute mobile medical apps, without engaging in manufacturing functions. Mobile Platform Manufacturer Anyone who commercially markets a mobile platform with an intended use of, or to be used with, a device. Excludes entities that solely distribute or market its platform with no device intended use.

34 MRC Strategy for Success Work within the existing regulatory framework Cooperate with FDA, accept appropriate level of risk based regulation while enabling innovation to flourish Clearly identify challenges and propose solutions from a big tent of participants. Don t just complain, solve Focus mhealth only Not intended to address HIT interoperability or acute care networked medical devices and HIT software issues Excludes physician use of tablets and smart phones within hospital Different complexities, use cases, and politics Single issue and common purpose Don t compete with industry trade organizations, cooperate Once we re done, we re done, on to the next challenge Not a zero sum game, 100% Stakeholder alignment

35 Questions? Thank you Dane Stout Executive Director Connected Health Practice Anson Group LLC x mobile