The document outlines the new Texas telemedicine law, Senate Bill 1107, which expands the definition of telemedicine and removes the requirement for in-person consultations, aiming to enhance health care access and address payment transparency. Key aspects include the standard of care that telemedicine services must adhere to and the conditions under which prescriptions can be issued remotely. It also discusses regulatory challenges, compliance, and the integration of technology in telemedicine practices.

1. Texas’ New Telemedicine Law
TMA 2017 Legislative Update
Jared Livingston
Assistant General Counsel
Texas Medical Association
Austin, Texas

2. • The Texas Medical Association (TMA) provides this information with the
express understanding that 1) no attorney-client relationship exists, 2) neither
TMA nor its attorneys are engaged in providing legal advice and 3) that the
information is of a general character. This is not a substitute for the advice
of an attorney. While every effort is made to ensure that content is
complete, accurate and timely, TMA cannot guarantee the accuracy and
totality of the information contained in this presentation and assumes no
legal responsibility for loss or damages resulting from the use of this content.
You should not rely on this information when dealing with personal legal
matters; rather legal advice from retained legal counsel should be sought. Any
legal forms are only provided for the use of physicians in consultation with
their attorneys.
• The information and opinions presented as part of this presentation should
not be used or referred to as primary legal sources, nor construed as
establishing medical standards of care for the purposes of litigation, including
expert testimony. The standard of care is dependent upon the particular facts
and circumstances of each individual case and no generalization can be made
that would apply to all cases.
DISCLAIMER

3. Learning Objectives
• Learn the new Texas telemedicine law
• Navigating the regulatory and business challenges
of telemedicine
• Texas call coverage agreements and the interplay
with telemedicine practices
• Strategies for operationalizing telemedicine and
digital health opportunities including practice,
compliance, and business solutions

4. • Senate Bill 1107 by Sen. Charles Schwertner, MD
• Collaboration between TMA, TAFP, and TeHA
Learning Objective 1:
The New Telemedicine Law

5. • Payment issues: frustrations over inability to be
reimbursed for telemedicine services provided to
patients
• Teladoc v. Texas Medical Board
– TMB rules required a face-to-face encounter prior to issuance
of a prescription
– Federal Trade Commission and Department of Justice
supported Teladoc’s position, asserting that TMB rules had
anticompetitive effects
How did we get here?

6. • SB 1107 represents a significant paradigm shift
• Elimination of two significant barriers:
– Expansion of the definition of telemedicine
– Removes the blanket requirement for in-person or
face-to-face visits
• Adds transparency for insurance reimbursement
Senate Bill 1107

7. • “A health care service delivered by a physician licensed in
this state, or a health professional acting under the delegation
and supervision of a physician licensed in this state, and acting
within the scope of the physician ’s or health professional ’s
license to a patient at a different physical location than
the physician or health professional using
telecommunications or information technology”
• Removes requirement for “advanced” telecommunications
technology
• Removes restriction on the use of phone or fax
Expansion of Definition

8. • Texas Medical Board may no longer impose an
across-the-board a face-to-face consultation
between a new patient and physician after an initial
encounter
• BUT the medical board is still authorized to ensure
that “patients using telemedicine medical services
receive appropriate, quality care”
Remove general requirement for face-
to-face visits

9. • Removing restrictions in definition created need
for patient protections in other areas of the bill
– Standard of care clarification
– Technology standards or relationship requirements
when issuing a prescription
What is now required?

10. • “A health professional providing a health care
service or procedure as a telemedicine medical
service or a telehealth service is subject to the
standard of care that would apply to the
provision of the same health care service or
procedure in an in-person setting.”
• Applies in all distant settings
Standard of Care
New patients Existing patients Call coverage
Issuing a prescription No prescription

11. • Does a telemedicine medical service meet the in-
person standard of care?
– If the patient were in your office, would (or should?) you
perform a physical exam?
– Can the patient convey or otherwise provide everything
you’d need to know to diagnose and treat?
– Is the treatment or diagnosis provided through
telemedicine reasonable and justifiable in an in-person
setting?
– Different treatment may not mean unreasonable treatment
Standard of Care

12. Technology and Relationship Requirements
Encounter that results
in prescription
Encounter that does
not result in
prescription
• Whether a physician is subject to
additional requirements turns on
he or she issues a prescription
Standard of Care?
Technology/relationship
requirements

13. • If issuing a prescription through telemedicine,
must satisfy one of these three requirements:
Technology and Relationship Requirements
1. Have an existing patient-
physician relationship
2. Be contacting the
patient pursuant to a call
coverage agreement that
meets TMB rules
3. Meet applicable
technology standards

14. 1. Existing patient-physician relationship
- TMB new rules do not clarify what this is
- Previously, it was patient ID verification, patient history, establishing a
diagnosis, appropriate testing, discussing diagnosis and follow-up care
- More generally, “the relationship of physician and patient is contractual
and wholly voluntary, created by agreement, expressed or implied.”
2. Call coverage: two models
a. Non-reciprocal. When physicians are not of same or similar specialty or
do not require reciprocal coverage: agreement must be in writing
b. Reciprocal. For same or similar specialty: agreement may be oral or in
writing
Relationship Requirements

15. Technology Requirements
New Patient and Not Call Coverage?
1. Follow up:
Provide appropriate
follow-up instructions
and, with consent, send
record to PCP; and
2. Use Proper Technology:
Provide the services with
one of the following
methods
3. Relevant Clinical Info:
Have access to and use
the relevant clinical
information the standard
of care requires; and
a. Real-time audiovisual
interaction; or
b. Store and forward
technology, as long as
accesses certain required
clinical information; or
c. Other form of
audiovisual interaction
that meets the standard
of care

16. • No tele-abortions
• Mental health exemptions continue
• Coordination among TMB, Board of Nursing,
Physician Assistant Board, and Pharmacy Board
Other provisions

17. • Fosters payment transparency
– Health plans required to adopt and post telemedicine
policies and payment practices
• Attempts to add clarity that telemedicine
services should not be a distinct benefit, but is
delivery method for existing benefits
Payment Provisions

18. Learning Objective 3:
Navigating regulatory challenges of
telemedicine

19. Regulations Governing Telemedicine
• Professional Conduct
– Medical Practice Act (and
other state practice acts)
– Physician Licensure –
Interstate Medical Licensure
Compact
– Prescriptions – DEA
enforcement actions and Ryan
Haight Act
– State Medical Board
Regulations
– Malpractice and Insurance
• Technology
– FDA – medical devices
– FCC – wireless spectrum
• Data Privacy and Security
– HIPAA/HITECH
– FTC –
• Breach Notification Rule
• Truth in advertising and data
privacy
– HIT interoperability
– State Privacy and Security Laws
• Compliance
– Stark
– Anti-Kickback
– State law
• Medicare/Medicaid
– Conditions of Participation
– Joint Commission Standards

20. Telemedicine and Digital
Health: New Texas Law,
Opportunities and Challenges
2017 TMA Fall Conference
Julian Rivera
Partner, Husch Blackwell, LLP
Austin, Texas
Julian.Rivera@HuschBlackwell.com
(512) 479-9753

21. © 2017 Husch Black well LLP
Learning Objectives
 Jared Livingston, TMA:
1. Learn the new Texas telemedicine law
2. Navigating the regulatory and business challenges
of telemedicine
3. Texas call coverage agreements and the interplay
with telemedicine practices
 Julian Rivera, Husch Blackwell:
4. Business challenges and regulatory interplay
5. Strategies for operationalizing telemedicine and
digital health opportunities including practice,
compliance, and business solutions

22. © 2017 Husch Black well LLP
Learning Objective 4
 Strategies for operationalizing telemedicine and other
digital health opportunities.

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Babyscripts (technology example)
 Doctor-delivered digital health tool (app) that is a “to-do
list” that guides mother through each gestation period
with practice-specific, provider-approved tasks
– Includes an internet-enabled scale and blood
pressure cuff – “Mommy Kit”
 Readings are automatically uploaded to mother’s
Babyscripts profile. Permits real-time feedback and
intervention from the comfort of the patient’s home.

25. © 2017 Husch Black well LLP
Regulations for Medical Technology
 Professional Conduct
– Heightened duty of care will vary from device to device
 What data is produced? How reliable is the data?
 Active patient monitoring?
 Technology
– FDA – medical devices, accessories to medical devices, and medical device data systems
– FCC – wireless spectrum
– CLIA – Direct to Consumer Testing
– International Considerations
 Data Privacy and Security
– OCR – HIPAA/HITECH
– FTC – Breach Notification Rule and Consumer Protection Rules
– ONC – standard development & coordination
– COPPA – Children’s Online Privacy Protection Act
– State Privacy and Security Laws
 Ethical Considerations
– Use of Personal Data
– Reliance on data vs. professional medical judgment
– Diagnosis made based on patient produced data

26. © 2017 Husch Black well LLP
Telemedicine Contracting – Transaction
Models
 Technology Services Agreement
– Originating Site contracting with technology vendor to
provide telemedicine platform
 Professional Medical Services Agreement
– Originating Site contracting with Distant Site to
provide professional medical services via a
telemedicine platform
 Both

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Managing Risk
 Legal Risk
– Mitigated through the written agreement
 Indemnification
 Limitation of Liability and Damages
 Security Obligations
– Consider impact of Force Majeure clause
 Warranties
 Business Risk
– Buyer has leverage
 Does the technology/service lower expenses or increase
revenue?
– Develop performance & satisfaction based on shared risk
– Establish performance expectations – Service Level Agreement
– Conduct a due diligence

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Technology Agreements
 Privacy and Security (BAA?)
– Tech vendor likely a Business Associate
– HHS Cloud Service Guidance – no conduit exception
 Audit Rights (Privacy/Security/Compliance)
 Compliance (Stark, Anti-Kickback, False Claims Act)
– Potential referral source?
 Intellectual Property
– Who owns original data or derivative data?
 Hardware/Software Ownership & Compliance (FDA)
 Portal User Interface (FDA/FTC)
– Terms of Use – Patient & Provider
– Data user interface post-termination of agreement

29. © 2017 Husch Black well LLP
Technology Agreements
 Specifications for Networks & User Interfaces
 Warranties & Representations (eg. FDA/FTC)
 Uptime/Downtime
– Service Level Agreement – analyze interplay between SLA &
BAA
– Tie to potential bonus payment or discount
– HHS Cloud Service guidance requirement
 Indemnity (have a “Plan B” too)
 Insurance
 Liability Waivers
 Marketing (use of trademark, name, likeness, etc.)
 Post-Termination
– Transition Services?
– Data Return/Destruction?

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Professional Services Agreements
 Parties
– Hospital or Physician Group
 Privacy and Security (BAA?)
– Provider should also be a covered entity
– Security obligations still vital
 Audit Rights (Privacy/Security/Compliance)
 Compliance (Stark, Anti-Kickback, False Claims Act)
– Referral Source
 Intellectual Property
– In the future will a telemedicine platform be built in-house or from
another vendor?
 Hardware/Software Ownership or License and Compliance (FDA)
– Who is responsible for providing certain technology?
 Portal User Interface
– Additional terms of use related to the technology?
– Pass through terms and conditions from the technology agreement?

31. © 2017 Husch Black well LLP
Professional Services Agreements
 Professional Standards
– Licensure: Out-of-State?
– Standard of Care
– Establishing Physician-Patient Relationship
 Medical Record Ownership Copies provided to Originating Site?
How quickly? Access to Originating Site EMR?
 Warranties & Representations (FDA/FTC)
 Uptime/Downtime
– Call response time
 Indemnity (have a “Plan B” too)
 Insurance
 Liability Waivers
 Marketing (use of trademark, name, likeness, etc.)
 Adherence to a Party’s Policies & Procedures

32. © 2017 Husch Black well LLP
Guidance Available
 ONC HIT has issued guidance related to contracting for
Electronic Health Record Systems
– Structure can be applied to other technology
agreements
– EHR Contracts Untangled
 HHS has issued guidance related to the use of cloud
service providers by HIPAA covered entities
– Guidance on HIPAA & Cloud Computing

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FDA Considerations – Medical Devices
 FDA ‘medical device’ or ‘accessory’
– Class I, II, III
– Regulatory Category
 New category or existing?
 510k process
– Collection of use data
 Physician inventor
– Who is using the device?
 FDA Medical Device Accessory Guidance
 New and Overriding!:
– FDA Digital Health Innovation Plan

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Mobile Apps
 Is a mobile healthcare app a medical device?
 FDA Mobile App Guidance – FDA will regulate certain
apps
– App connects to a device for purposes of controlling
the device or for use in active patient monitoring or
analyzing medical device data.
– Uses attachments, display screens, or sensors or by
including functionalities similar to those of currently
regulated medical devices.
– Performs patient-specific analysis and provides
patient-specific diagnosis, or treatment
recommendations.

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Mobile Apps
 What apps will not be regulated?
– Help patients (i.e., users) self-manage their disease
or conditions without providing specific treatment or
treatment suggestions
– Provide patients with simple tools to organize and
track their health information
– Provide easy access to information related to patients’
health conditions or treatments

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Medical Device Data Systems
• A Medical Device Data System (MDDS) is a hardware or
software product that transfers, stores, converts formats,
and displays medical device data
• An MDDS does not modify the data, and it does not
control the functions or parameters of any connected
medical device. An MDDS does not include devices
intended for active patient monitoring.
• FDA Medical Device Data System Guidance
 The FDA does not intend to enforce compliance with
the regulatory controls that apply to an MDDS so long
as it meets the definition set forth above.

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Mobile Health Privacy
 OCR/ONC/FTC tool
 OCR Mobile App Developer Portal
 HIMSS Mobile Health Security Kit
 Is mobile app a business associate?
– Yes – HIPAA
– No – FTC Health Record Breach Notification Rule
 AMA mHealth Application Principles

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Learning Objectives
 Learn the New Texas Telemedicine Law
 Navigating the regulatory and business challenges of
telemedicine
 Texas call coverage agreements and the interplay with
telemedicine practices
 Strategies for operationalizing telemedicine and digital
health opportunities including practice, compliance, and
business solutions

41. © 2017 Husch Black well LLP
Questions?

42. © 2017 Husch Black well LLP
Glossary of Linked Resources
1. Texas Legislature Gives Telehealth a Call Back – Husch
Blackwell Healthcare Law Insights -
http://www.healthcarelawinsights.com/2017/07/texas-
legislature-gives-telehealth-a-call-back/
2. EHR Contracts Untangled – ONC Health IT -
https://www.healthit.gov/sites/default/files/EHR_Contracts_U
ntangled.pdf
3. Guidance on HIPAA & Cloud Computing – HHS -
https://www.hhs.gov/hipaa/for-professionals/special-
topics/cloud-computing/index.html
4. Medical Device Accessories – Describing Accessories and
Classification Pathway for New Accessory Type – FDA -
https://www.fda.gov/downloads/medicaldevices/deviceregulat
ionandguidance/guidancedocuments/ucm429672.pdf

43. © 2017 Husch Black well LLP
Glossary of Linked Resources
 Mobile Medical Applications – FDA -
https://www.fda.gov/downloads/medicaldevices/devicere
gulationandguidance/guidancedocuments/ucm263366.p
df
 Medical Device Data Systems Guidance – FDA -
https://www.fda.gov/downloads/medicaldevices/devicere
gulationandguidance/guidancedocuments/ucm401996.p
df
 OCR/ONC/FTC Tool - https://www.ftc.gov/tips-
advice/business-center/guidance/mobile-health-apps-
interactive-tool
 OCR Mobile App Developer Portal -
http://hipaaqsportal.hhs.gov/

44. © 2017 Husch Black well LLP
Glossary of Linked Resources
 HIMSS Mobile Health Security Kit -
http://www.himss.org/mobile-health-privacy-security
 AMA mHealth Application Principles - https://www.ama-
assn.org/ama-adopts-principles-promote-safe-effective-
mhealth-applications
 Calls and text messages from healthcare organizations:
New developments under the TCPA’s ’emergency
purpose’ exception – Husch Blackwell Healthcare Law
Insights-
http://www.healthcarelawinsights.com/2016/08/calls-and-
text-messages-from-healthcare-organizations-new-
developments-under-the-tcpas-emergency-purpose-
exception/