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mHealth:
Regulation and How to Avoid
Practicing Medicine on the
Web
Scott A. Edelstein, Esq.
Partner
Squire Sanders
37 Offices in 18 Countries
Karl M. Nobert, Esq.
Of Counsel
Squire Sanders
mHealth Trends
• 81% of physicians have a smartphone1
• 45% of U.S. adults own smartphones
• 52% of smartphone owners have used their phone to look for
health information
• 19% of smartphone owners have at least one health app on their
phone.2
• 13,000 health, medical and fitness apps
2
1. 2011 Manhattan Research
2. 2012 Pew Research Mobile Health Report
The Medical Device
Classification System
3
Medical Device Classification
• 3 Classes of Medical Devices
• Class I (low risk)
• Class II (medium risk)
• Class III (high risk and novel devices)
• Classes based on control levels
4
Risk Based Classification
1700+ Generic Devices
510(k) Exempt
Class I
Class II
Class III
Very low
Low (~782)
Medium (~799)
High (~119)
General Controls
(may or may not be
GMP exempt)
General Controls
Premarket
Notification or 510(k)
General & Special
Controls
510(k) submission
General & Special
Controls
Premarket Approval
Level of Risk & Level of Regulatory Control
5
Examples
• Medical Device Classes:
–Class I
–General Controls
–Most exempt from premarket
submission
»Class II
»Special Controls
»Premarket Notification [510(k)]
–Class III
–Require Premarket Approval [PMA]
6
Device Classification
Class I – Low Risk Devices
- Registration and Listing
- Labeling
- Good Manufacturing Practices (Quality
System Regulation)
- Medical Device Reporting
7
CONTINUED
What are General Controls?
•
•
Basic authorities that
provide FDA with the
means to regulate medical
devices.
Applies to all medical
devices regardless of
classification, are subject
to premarket and
postmarket regulatory
controls.
- Establishment
registration and device
listing
- Premarket notification or
510(k), if not exempt
- Labeling
- Misbranding
- Adulteration
- Quality Systems
- Records and Reports / Medical Device Reporting
(MDR)
8
Device Classification
Class II – Medium Risk Devices
•
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General Controls Plus Special Controls
-
Performance Standards
Post-Market Surveillance
Patient Registries
Guidelines
-
Other Appropriate Actions
CONTINUED
What are Special Controls?
•
Postmarket
Surveillance Study
•
Patient Registries
•
Guidelines (e.g., Glove
Manual)
•
Mandatory
Performance Standard
•
Recommendations or
Other Actions
•
Special Labeling (e.g.,
882.5970, Cranial
Orthosis)
• General controls alone are
insufficient to assure safety and
effectiveness of Class II devices
• Existing methods are available to
provide such assurances.
• Special controls may include
special labeling requirements,
mandatory performance standards
and postmarket surveillance.
• A few Class II devices are exempt
from the premarket notification.
10
Device Classification
CONTINUED
Class III – High Risk Devices
11
-
Life Sustaining
-
Life Supporting
-
Implants
-
Unreasonable Risk Of Injury Or Illness
FDA’s Regulation
of Mobile Medical Devices
and Smartphone Applications ("apps")
12
Statutory Authority
(h) The term "device" … means an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or
other similar or related article, including any component, part, or
accessory, which is
(1) recognized in the official National Formulary, or the United
States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention
of disease, in man or other animals, or
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(3) intended to affect the structure or any function of the body of
man or other animals, and which does not achieve any of its
principal intended purposes through chemical action within or on
the body of man or other animals and which is not dependent upon
being metabolized for the achievement of any of its principal
intended purposes.
What is an “app”?
• A Mobile Application or “app” is:
 a software program that runs on smartphones and
other mobile communications devices
Examples: apps to monitor caloric intake for healthy weight
maintenance, to allow doctors to view a patient's X-rays on
their mobile device
FDA intends to apply its regulatory requirements solely to a
subset of mobile apps that it is calling mobile medical
applications or "mobile medical apps."
14
Apps that FDA Intends to Regulate
• Only those that meet the statutory definition of a
device; and either:
• are used as an accessory to a regulated
medical device; or
• transform a mobile platform into a regulated
medical device.
15
FDA’s Proposed Regulatory Approach
Mobile
Medical Apps
Other mobile apps that
meet “device” definition
Not considered mobile apps
16
FDA’s Proposed Regulatory Approach
• Apps that FDA intends to regulate
• May be classified as class I (general controls), class II
(special controls in addition to general controls), or class
III (premarket approval)
• Other Apps + Enforcement Discretion
• The Applicability of the Quality System Regulation
17
App Categories and Classifications
1) Displaying, storing or transmitting patient-specific medical
device data in its original format – An MDDS (21 CFR
880.6310) (Class I)
2) Controlling the intended use, function, modes, or energy
source of the connected medical device- An Accessory Required to comply with the controls applicable to that
connected device.
3) Transforming or making the mobile platform into a
regulated medical device – Radiological Image Display (21
CFR 892.2050) (Class II)
4) Creating alarms, recommendations or creating new
information (data) by analyzing or interpreting medical
device data – Cardiac Monitoring Software (21 CFR 870.2300)
18
Examples of Regulated Apps
19
Reg. #
Medical Device
Class # Filing
868.1900
Calculator, Pulmonary Function
Interpretation (Diagnostic)
II
510(k)
870.1110
Computer, Blood-Pressure
II
510(k)
892.2010
Device, Digital Image Storage,
Radiological
1
510(k)
Exempt
870.2800
Electrocardiograph, Ambulatory,
With Analysis Algorithm
II
510(k)
868.2377
Monitor, Apnea, Home Use
II
510(k)
884.2660
Monitor, Ultrasonic, Fetal
II
510(k)
878.4810
Over-The-Counter Powered Light
Based Laser For Acne
II
510(k)
880.2700
Scale, Stand-On, Patient
1
510(k)
Exempt
884.2900
Stethoscope, Fetal
1
510(k)
Exempt
Examples of Recently FDA Reviewed
Mobile Medical Apps
20
FDA Cleared Mobile Medical App
ASTRA Picture Archiving Communications Systems
(K111694) (Candelis, Inc.) (9/15/11)
• Device Description: ASTRA is a web-enabled software app
that provides image processing and viewing tools and access to
studies and reports from a Local Area Network, Wide Area
Network, remote workstation, personal computer, or an iPhone,
or iPad via a Virtual Private Network connection.
• Intended Use: ASTRA is software image management
intended to receive, process, review, display, print and archive
medical images and data from imaging modalities (e.g., CR and
DR).
21
FDA Cleared Mobile Medical App
Carestream PACS (K110919) (Carestream Health, Inc.)
(10/20/11)
• Device Description / Intended Use: is an image
management system whose intended use is to provide
completely scaleable local and wide area PACS solutions for
hospital and related institutions/sites, which will archive,
distribute, retrieve and display images and data from all hospital
modalities and information systems.
22
FDA Cleared Mobile Medical App
Mobile MIM PACS (K112930) (MIM Software, Inc.)
(12/2/11)
• Device Description: In addition to SPECT, PET, CT, MRIf
modalities, Mobile MIM can be used for the viewing Mnd/or
display for diagnosis of X-ray and Ultrasound medical images.
• Intended Use: The Mobile MIM software program is used for
the viewing, registration, fusion, and/or display for diagnosis of
medical images from the following modalities: SPECT, PET, CT,
MRI, X-ray and Ultrasound.
23
Regulatory Collaboration
and Enforcement
24
Regulatory Collaboration
• Agency Cooperation
• FTC’s Broad Mandate
- Publications:
•
•
Report: “Mobile Apps for Kids: Current Privacy Disclosures are Disappointing”
(Feb. 2012)
Guidance Document: “Marketing Your Mobile App: Get It Right from the Start”
(Aug 2012)
• Other Agencies with Potential Involvement
25
Regulatory Enforcement
• Potential FDA Enforcement Action
- Untitled and Warning Letters
- Failure to comply with the device regulations
- Unsupported labeling claims
• FTC Enforcement Action
- Deceptive Advertising
- Unsubstantiated Claims
- Financial Forfeiture
- Recent mHealth Examples
26
Pursuing Medicare / Medicaid
Reimbursement for Medical Devices
27
FDA / CMS Parallel Review Program
• A recently created joint-Agency program that
• allows for the simultaneous review for FDA medical
device clearance and Medicare reimbursement approval
• is designed to reduce the time between receiving FDA
marketing approval and a Medicare national coverage
determination.
28
Candidates for Parallel Review
FDA and CMS have restricted this phase of parallel review for
those innovative medical devices that meet one of the following
criteria:
• New technologies for which the applicant has had sufficient preinvestigational device exemption (“IDE”) interaction with FDA or
an approved IDE application;
• New technologies for which an original or supplemental approval
or petition for de novo review would be required; or
• New technologies that fall within the scope of a Part A (inpatient)
or Part B (outpatient) Medicare benefit category and are not
subject to the NCD.
29
Parallel Program Phases
• Nomination – The sponsor of an innovative therapeutic or
diagnostic device may nominate its device for participation in the
parallel review program.
• FDA/CMS Review – FDA and CMS will meet to consider a
nomination within 30 days of receipt of nomination package.
• Notification of Acceptance – After the agencies’ meeting, the
applicant will be notified whether its device is an appropriate
candidate for the program.
• Acceptance Meeting – If the applicant is deemed to be an
acceptable candidate, FDA and CMS will meet with the applicant
either in person or by telephone.
• FDA Review – Parallel review candidates will be reviewed
according to the normal FDA review process.
• CMS NCD Review and Timing – CMS will begin
its informal review process sometime
after the submission of the PMA or de novo petition.
30
Regulatory Implications of
Using Apps for Telemedicine
31
Telemedicine
Hospital Hub
Telemedicine practitioners
Developing Areas in Telemedicine
• Licensure
• Reimbursement
• Confidentiality
• Liability
33
Interstate Practice of Medicine
• Statutes in several states specifically provide that furnishing
telemedicine services to a patient constitutes the practice of
medicine in that state.
 E.g., Oregon law requires a license for the practice of medicine across
state lines and defines the practice of medicine across state lines as:
– (1) The rendering directly to a person of a written or otherwise
documented medical opinion concerning the diagnosis or treatment of
that person located within this state for the purpose of patient care by a
physician located outside this state as a result of the transmission of
individual patient data by electronic or other means from within this
state to that physician or the physician's agent
34
Interstate Practice of Medicine (cont’d)
• Exceptions to general licensure requirement:
 Consultation Exception
 Emergencies
 Special or Temporary Telemedicine License
 Licensure by Endorsement
35
Consultation Exception
• Most states allow physicians
licensed in another state to provide
consultations to local physicians
• Scope of the exception varies by
state
36
Consultation Exceptions
No Statutory Exception
Narrow Exceptions
Broad Exceptions
Consultation Exception (cont’d)
• Exceptions can be grouped into 9 categories:
 General Consultation Exception
 Infrequent Consultation Exception
 Prohibition of Local Office
 Local Physician Responsibility
 Local Physician Request
 Primary vs. Secondary Requirements
 Combination Exceptions
 Unique Exceptions
 Uncompensated Consultations
38
Consultation Exception (cont’d)
• Typical “general” consultation exception statute provides:
 “The following persons under the following limitations may practice
medicine within the state without a license: (3) Any physician who is
licensed in another state or country and who is meeting a physician
licensed in this state, for purposes of consultation, provided such
practice is limited to such consultation[.]” N.Y. Educ. L. § 6526(3).
39
Special or Temporary Licenses
• 9 states issue special or temporary telemedicine licenses
Washington
Montana
North
Maine
Dakota
Vermont
Minnesota
Oregon
Idaho
New
Hampshire
South
Dakota
Wisconsin
Nevada
Michigan
Utah
Connecticut
Iowa
Nebraska
Pennsylvania
Illinois
California
Massachusetts
New York
Wyoming
Indiana
Ohio
Kansas
Missouri
Virginia
Kentucky
North Carolina
Tennessee
Arizona
Oklahoma
Arkansas
New Mexico
South
Carolina
Mississippi Alabama
Georgia
Texas
Louisiana
Florida
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New Jersey
Delaware
Maryland
West
Virginia
Colorado
Rhode Island
Licensure by Endorsement
• Many states provide for licensure of physicians who are licensed
in another state
• Process typically requires:
 Application
 Payment of fee (typically around $200)
 Verification of licensure from all other states where applicant is
licensed
 Score reports from exams
 Fingerprinting
41
Strategies for Interstate Practice
Strategy
Pros/Cons
Using only physicians licensed
in state where they will practice
Least efficient model, but lowest
regulatory risk
Structuring arrangement to fit
within some combination of
various consultation exceptions
Most efficient model. Allows for
operation in many, but not all
states.
Combination of all of the above
Can allow for operation in all
states
Interstate Practice and Nurse Licensure
Interstate Nurse Licensure Compact
 Allows nurse licensed in any participating state to
practice without additional licensure in any other
participating state
 Introduced in 1999
 24 states now participate in the compact
43
Interstate Nurse Licensure Compact:
Participating States
Washington
Montana
North
Maine
Dakota
Vermont
Minnesota
Oregon
Idaho
New
Hampshire
South
Dakota
Wisconsin
Nevada
Michigan
Nebraska
Utah
Connecticut
Iowa
Pennsylvania
Illinois
California
Massachusetts
New York
Wyoming
Indiana
Ohio
Kansas
Missouri
Virginia
Kentucky
North Carolina
Tennessee
Arizona
Oklahoma
Arkansas
New Mexico
South
Carolina
Mississippi Alabama
New Jersey
Delaware
Maryland
West
Virginia
Colorado
Rhode Island
Georgia
Texas
Louisiana
Florida
Nurse Licensure: Non-Compact States
• Every state allows for licensure by endorsement, so long as
licensure requirements of applicant’s state are as stringent as
requirements in endorsing state
• Some states require nurses licensed by endorsement to complete
state-specific continuing-education requirements
 E.g., Florida requires completion of a course on Florida laws and
rules relating to the practice of nursing
45
Malpractice and General Liability
• Physician-patient relationship
• Standard of care
• Jurisdiction
• Choice of law
• Insurance coverage
• Recording encounters
46
Informed Consent
• Oral and written consent
• Translation
47
Requirements Related to Prescribing
Drugs
Ryan Haight Online Pharmacy Consumer
Protection Act of 2008 (Pub. L. No. 110-425)
 Prohibits online pharmacies from dispensing
controlled substances without a valid prescription
from a physician who has examined the purchaser
in person
48
Requirements Related to Prescribing
Drugs
 Many states require that a physician
physically examine a patient before
prescribing drugs for the patient (but not IL,
PA, NY, NV and a few others)
 Every state prohibits “unprofessional
conduct”
 Numerous state medical boards have issued
policies prohibiting prescriptions “based
solely on an on-line questionnaire or
consultation.”
 Exceptions
49
Requirements Related to Prescribing
Drugs
• Exceptions:
 “Prescribing for a patient whom the physician has not personally
examined may be suitable under certain circumstances. These may
include, but not be limited to . . .prescribing for a patient of another
physician for whom the prescriber is taking call, or continuing
medication on a short-term basis for a new patient prior to the
patient’s first appointment. Established patients may not require a new
history and physical examination for each new prescription, depending
on good medical practice.” Alabama State Board of Medical
Examiners Rule 540-X-9-.11
50
Corporate Practice of Medicine
Restrictions
• Many states prohibit lay corporations from practicing medicine
• In such states, physicians cannot be employed by a lay
corporation
• Presents challenges for multi-state corporations
• Captive or “friendly” PC as a work-around
• 14 states allow for an exception to licensing rules to allow
doctors to practice telemedicine in certain circumstances
51
Captive PC Model
Stock Transfer
Restriction Agrmt.
Licensed
practioner
Consulting Agrmt.
$
Management
Agrmt.
PC
52
$
Telemedicine Company
Medicare Reimbursement
Originating
Site
(HPSA or
non-MSA)
53
Eligible Sites
•Physician or practitioner office
•Inpatient or outpatient hospital
•Critical access hospital
•Federally qualified health ctr.
•Rural health clinic
•Hospital-based or critical
access hospital ESRD
•Skilled nursing facility
•Community mental health ctr.
Distant Site
Eligible Providers
•Physician
•Nurse Practitioner
•Physician Assistant
•Nurse midwife
•Clinical nurse specialist
•Clinical psychologist
•Clinical social worker
•Registered dietitian
Medicare Eligible Medical Services
• Initial inpatient and follow-up inpatient consultations
• Subsequent hospital care services
• Subsequent nursing facility care services
• Office or other outpatient visits
• Individual psychotherapy
• Pharmacologic management
• Psychiatric diagnostic interview examination
• End stage renal disease related services
54
Medicare Eligible Medical Services (cont’d)
• Individual and group medical nutritional therapy
• Neurobehavioral status exam
• Individual and group health and behavior assessment and
intervention
• Individual and group kidney disease education services
• Individual and group diabetes self-management training services
• Smoking cessation
55
CY 2013 Proposed Medicare Eligible
Services
• Alcohol and/or substance abuse assessment and intervention
• Alcohol misuse screening and behavioral counseling
• Depression screening
• Behavioral counseling to prevent STIs
• Behavioral therapy for cardiovascular disease
• Behavioral counseling for obesity
56
Medicare Reimbursement
Conditions of Payment
• Telehealth provider reimbursed per Medicare fee schedule
• Telepresenter not required
• Facility fee for originating site (currently $24.24)
57
Medicaid Reimbursement
No Medicaid Reimbursement
Medicaid Reimbursement
Private Payor Reimbursement
• Slow adoption
• Only thirteen states have government mandated private payor
reimbursement
59
Legal Issues
• Fraud and Abuse
 Federal and state antikickback laws
 OIG opinions (98-18, 99-14, 03-4)
60
Legal Issues
• Self-Referral Laws
 Federal and state laws
• False Claims Act
• Civil Monetary Penalties
61
Data Privacy and Security
• HIPAA
• State laws
• EU Privacy Directive
• Other foreign data privacy laws
• FTC
 Truth in advertising
 Honor your privacy promises
 Clear, easy-to-read on small screen
 Revisions
• Voluntary Privacy Code of Conduct
 Short-form notice
62
HIPAA Risks of Telemedicine
• Computerization enables storage of large amounts of data in
small spaces.
• Networked information is accessible from anywhere at any time.
• New databases and different types of data sets are more easily
created.
• Information is easily gathered, exchanged and transmitted.
• HIPAA and OCR
 OCR enforces HIPAA, and it clearly applies to the
transmission of protected health information by smartphones
 The loss of a smartphone may trigger breach notification
requirements
 ONCHIT notes that mobile phones on the market meet no
more than 40% of the security requirements of HIPAA or
meaningful use Stage 2 standards; after manual configuration,
compliance runs as high as 60%, according to some experts
63
State Data Breach Laws
• 40 states have enacted legislation requiring disclosure for
security breaches
• Legislation pending in 8 states
• Applies to businesses that maintain computerized data
• Requires written notification
• Personal information acquired by unauthorized person
64
Mission Impossible?
65
65
Contact Information
Scott A. Edelstein
Partner
Squire Sanders (US) LLP
1200 19th Street, NW
Washington DC 20036
[email protected]
202.626.6602
415.954.0205
Karl M. Nobert
Of Counsel
Squire Sanders (US) LLP
1200 19th Street, NW
Washington DC 20036
[email protected]
202.626.6630
66