Worldwide: Digital Health Law Update Vol. 1 Issue 5

Industry Insights

Jones Day partners Todd Kelly and Elizabeth Myers and associate Eric Jackson recently coauthored an article titled "While Rules Evolve Telemedicine is Alive and Well in Texas," published in Texas Lawyer. The article explores various telemedicine models that are being used in America's second most populous state, despite the uncertainty and litigation disputes regarding recent amendments to the Texas Medical Board's rules on telemedicine and prescribing that threaten some direct-to-consumer delivery models. The article concludes that "little has changed consultations among licensed providers or referrals by physicians who have already evaluated the patient."

Reprinted with permission from the September 2015 edition of Texas Lawyer. © 2015 ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited.

Federal Features

ONC—The Office of National Coordinator for Health Information Technology ("ONC") recently released a white paper, titled Designing the Consumer-Centered Telehealth & eVisit Experience: Considerations for the Future of Consumer Healthcare, which ONC had commissioned as a summary of its April 2015 design workshop on the topic.

According to the paper, the workshop identified the following nine guidelines for consumer-centered telehealth:

  • There cannot be friction for the user.
  • Team-based care must include smart triggers.
  • Real world and online world must converge.
  • We must be sensitive to data overload.
  • Consumers are the hubs of their own health care data.
  • Converge data for interactions to be safe and meaningful.
  • Expand role for care team based on new data triggers.
  • Integrate technology and human interaction in the physical world.
  • Increase focus on patient data security.

Although the paper explains that it should not be interpreted as a policy statement of ONC, it does provide an overview of the state regulatory landscape, other challenges faced by telehealth providers, and general principles for what it describes as four levels of the integration-to-fracturing of care: (i) integrated care (primary care provider ("PCP"), patient, and family members); (ii)telehealth-enabled care (use of telehealth by same PCP); (iii) extended integration (telehealth-enabled encounter with networked providers); and (iv) outside care (telehealth-enabled encounters with "one-off" clinicians, i.e., no preexisting relationship). The white paper indicates that ONC expects to continue discussing these issues and has a stated goal of expanding the adoption and use of telehealth and mobile health.

FTC—On September 17, 2015, the Consumer Protection Bureau of the Federal Trade Commission ("FTC") released details of a recent enforcement action against the marketers of a mobile application that provides visual exercises focused on reading and other activities. Under the terms of a proposed settlement, the company has agreed to disgorge $150,000 and to stop making certain claims about the app. The FTC had alleged that the company did not have scientific evidence to support its claims that the app could improve users' vision. This action serves as a reminder of the importance for careful consumer disclosures and registration terms, especially for mHealth apps.

Telehealth Legislation—Members of Congress and outside organizations continue to discuss the Telemedicine for Medicare (TELE-MED) Act of 2015, which has been introduced in both the House of Representatives and Senate. The bill would enable physicians licensed in one state to provide care remotely to Medicare patients located in other states without obtaining a license in the patient's state. Although limited to Medicare services, the bill has a similar purpose as other initiatives aimed at streamlining professional medical standards, such as the Interstate Medical Licensure Compact, which has been adopted by 11 states.

State Summaries

Alabama—On August 19, 2015, the Alabama Board of Medical Examiners announced it had repealed and immediately suspended enforcement of its telehealth rules, explaining the decision was based on its concerns regarding potential antitrust issues following the recent U.S. Supreme Court decision in North Carolina State Board of Dental Examiners v. FTC. The repealed rules included an "appropriate physical examination" requirement that limited the use of certain telehealth delivery models in the state. The Board is not expected to issue replacement rules until the state legislature approves new telehealth legislation, possibly as early as spring 2016.

Colorado—On August 20, 2015, the Colorado Medical Board issued new guidelines on the appropriate use of telehealth in the context of "direct to consumer" business models. The guidelines closely track the Model Policy of the Federation of State Medical Boards by providing that a provider–patient relationship can be established via telehealth and that the same standard of care applies to both telehealth and in-person delivery models. Other notable features include: (i) the definition of "telehealth" covers both synchronous interactions and store-and-forward transfers; (ii) the use of telehealth requires informed consent with appropriate disclosures on the modality; (iii) a formal written protocol must be developed for handling emergency services; and (iv) recommendations of medical marijuana may not be made via telehealth technologies.

Idaho—The Idaho Board of Medicine recently adopted " Guidlinesfor Appropriate Regulation of Telemedicine." The guidelines mark a significant reform for a state that has been the source of relatively high-profile enforcement actions against telehealth providers. Specifically, the new policy recognizes that a physician–patient relationship may be established remotely but advises physicians not to render medical advice or care using telemedicine without verifying the location of the patient, disclosing the provider's identity and credentials, and obtaining any special informed consents regarding the use of telemedicine technologies, among other requirements. The Board is in the process of codifying these policies into regulations and held a public hearing on the matter on September 15, 2015.

North Carolina—Pursuant to a new rule effective August 1, 2015, North Carolina pharmacists are permitted to use professional judgment in refusing to fill a prescription in cases where the prescription order's accuracy, validity, or authenticity or the patient's safety is at issue. Additionally, the rule provides that a prescription order is valid "only if it is a lawful order for a drug, device, or medical equipment issued by a health care provider for a legitimate medical purpose, in the context of a patient–prescriber relationship, and in the course of legitimate professional practice." Previously, state law had imposed an obligation on pharmacists to decline prescriptions when it was believed the prescriber had not conducted "a physical [in-person] exam" of the patient. This change helps bring the pharmacy regulations in line with current policies of the state Medical Board as it relates to telemedicine.

South Carolina—At its August 3, 2015 meeting, the S.C. Board of Medical Examiners approved a telemedicine provider guidance document and updated its advice on establishing a physician–patient relationship as a prerequisite to prescribing drugs. The guidance document clarifies that telemedicine is held to the same standard of care as in-person services. With respect to establishing a physician–patient relationship, while the Board's updated guidance indicates that such a relationship can be established solely through telemedicine, the guidance appears to require the use of patient-site ancillary providers where there is no preexisting physician–patient relationship (with limited exceptions such as writing admission orders for a newly hospitalized patient, prescribing for a patient of another licensee for whom the prescriber is taking call, and others).

Virginia—Virginia recently amended its rules regarding telemedicine prescribing. As of July 1, 2015, a prescriber may establish a practitioner–patient relationship through "two-way, real-time" communication or store-and-forward technology if the licensed prescriber has a medical history available for review, makes the diagnosis at the time of prescribing, and conforms to standards of care for in-person treatment, among other requirements.

Wisconsin—In a notice dated September 21, 2015, the Wisconsin Medical Examining Board announced it has begun the process for proposing new telemedicine regulations. The current administrative code is silent with regard to telemedicine, but the proposed rule would define the practice of telemedicine, explain how a valid physician–patient relationship can be established in a telemedicine setting, and specify licensure and technology requirements for the use of telemedicine. The notice cites federal bill H.R. 691 (Telehealth Modernization Act of 2015) as a model for the issues that will be addressed by the Wisconsin proposed rule.

Reimbursement Review

Delaware—In September 2015, the Delaware Division of Medicaid and Medical Assistance ("DMMA") adopted an amendment recognizing the Medicaid beneficiary's home as an originating site for reimbursement of interactive, real-time audio-video telemedicine. In response to public comments, the DMMA also revised the final rule to include nonresidential day programs and alternate locations as originating sites.

Michigan—On September 16, 2015, Michigan legislators introduced Senate Bill No. 495, which would require coverage for asynchronous store-and-forward and real-time telemedicine provision of care as long as the provider is licensed in the state where the patient is located. Additionally, the legislation would clarify that insurance policies may "not require face-to-face-contact" for telemedicine services to qualify for reimbursement.

Texas—Effective September 1, 2015, an amendment to Texas Medicaid Rule § 355.7001 clarifies that physicians will be reimbursed for telemedicine services provided in a school-based setting even if the physician is not the patient's primary care provider. To qualify, the child must be located at school and enrolled in Medicaid. A health professional, such as a school nurse, must be present with the child during treatment, and the parent or guardian must give consent before the telemedicine services are provided.

Washington—The Washington Apple Health (Medicaid) program recently held a public hearing regarding a proposed rule that would cover "HIPAA-compliant, interactive, real-time audio and video telecommunications (including web-based applications) or store and forward technology [used] to deliver covered services that are within his or her scope of practice to a client at a site other than the site where the provider is located." Eligible originating sites would include clinics, hospitals, and patients' homes, among other listed locations. As the proposed rule goes though the rulemaking process, the program has temporarily implemented a less expansive rule that covers only real-time audio and video telemedicine.

Global Happenings

EU Digital Single Market—On September 23, 2015, the European Commission launched a public consultation on Standards for the Digital Single Market ("DSM"). Andrus Ansip, Commission Vice President for the Digital Single Market, explained that common standards and interoperability will "make the best of fast-growing sectors such as cloud computing and the Internet of Things." The Commission is gathering views on priorities for standards in key technology areas that are, in the Commission's opinion, critical to achieving the DSM and, once delivered, can constitute a technological foundation upon which other standards can be built. eHealth is one of the key topics on which the Commission is looking for input. Public comments are due December 16, 2015. Please contact Cristiana Spontoni if you are interested in discussing how we can assist you with submitting comments.

EU–US Data Protection—Telehealth providers hoping to bridge the North Atlantic face challenging issues for cross-jurisdictional compliance in the area of data protection. As a general principle, EU Directive 95/46/EC and national implementing legislation prohibit the processing of personal data related to health, except in certain conditions, such as obtaining the explicit consent of the data subject or where processing is required for the purposes of preventative medicine or medical care and is performed by health care professionals subject to confidentiality obligations. In the United States, the real issue concerning data protection is often which authorities apply: U.S. Department of Health and Human Services or Federal Trade Commission regulations, state-specific data privacy rules, or all of the above. This topic is explored in an August 2015 article in eHealth Law & Policy, coauthored by Jones Day partners Alexis Gilroy, Cristiana Spontoni, and Undine von Diemar and associate Katherine Llewellyn.

Upcoming Events

October 21, 2015: Maureen Bennett will give a presentation on International Clinical Research Issues to the Boston Bar Association's Health Law Education Committee.

October 26–27, 2015: Alexis Gilroy will speak about Lessons on Telemedicine—Opportunities and Unique Diligence and Payment Considerations at the AHLA Health Plan Counsel Institute in Chicago, IL.

November 19–20, 2015: Cathy Livingston will present on Compensation Issues and Joint Ventures, Subsidiaries, and Contractual Issues at the Western Conference on Tax Exempt Organizations in Los Angeles, CA.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Kevin D. Lyles
In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.