Jennifer Geetter and Lisa Schmitz Mazur wrote this bylined article on the regulatory implications of technology-supported devices, resources, and solutions that facilitate health patient-provider interaction. “Health industry regulators are struggling with how to apply the existing privacy regulatory regime, and the permitted uses and disclosures for which they provide, in this new world of healthcare innovation,” the authors wrote.
As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been actively monitoring Texas’ approach to telemedicine regulation and the related Teladoc case. Texas has eliminated its most restrictive requirement for delivering care via telemedicine in Texas, increasing opportunities for providers to reach patients using technology. Senate Bill 1107 was passed on May 11, 2017, and the House added an amendment in passing Senate Bill 1107, which was approved in the Senate on May 18. The bill was signed into law by Governor Abbott last weekend.
On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims. This settlement highlights for mHealth app developers the importance of systematically gathering sufficient evidence to support their commercial claims.
Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held devices—is empowering the innovation needed to meet the imperative for a transition from payment based on volume to payment based on value that is evaluated in terms of measurable improvements in care delivery and population health.
One prominent example is the use of digital health solutions to implement the payment innovation contemplated by the Medicare Access and CHIP Reauthorization Act (known as MACRA)—which directly ties both payment increases and reductions to various, specific efficiency and value measures. The Merit-Based Incentive Payment System (MIPS), one of the two available payment pathways under MACRA, assigns points to clinicians in different performance categories, several of which promote the adoption of digital health solutions. To illustrate:
For [...]
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In its tenth OCR Cyber Awareness Newsletter of the year (Newsletter), the Office for Civil Rights (OCR) reminded HIPAA-covered entities and business associates of the importance of selecting an appropriate authentication method to protect electronic protected health information (ePHI). Authentication is the process used to “verify whether someone or something is who or what it purports to be and keeps unauthorized people or programs from gaining access to information.” The Newsletter notes that the health care sector has been a significant target of cybercrime and that some incidents result from weak authentication methods.
Authentication methods can consist of one or more factors and are often described as: (1) something you know, such as a password; (2) something you are, such as a fingerprint; or (3) something you have, such as a mobile device or smart card. Single-factor authentication requires use of only one of the methods. Multifactor authentication requires use of two or more methods (for example, a password prompt followed by an additional prompt to a mobile device). (more…)
On August 3, 2016, the Federal Trade Commission (FTC) staff submitted public comments regarding the Delaware Board of Occupational Therapy Practice’s proposed regulation for the provision of occupational therapy services via telehealth in Delaware (the Proposed Regulation). The FTC’s comments to the Proposed Regulation follow its comments to Alaska’s telehealth legislation earlier this year and evidence its continued focus on telehealth’s ability to foster flexibility in health care delivery by increasing practitioner supply; encouraging competition; and improving access to affordable, quality health care.
By way of background, in 2015, Delaware amended its Insurance and Professions and Occupations Code (the Code) to include the regulation of telehealth and telemedicine services, including the delivery of occupational care remotely under existing, in-person standards of care. Consistent with the Code, the Delaware Board of Occupational Therapy Practice (the Board) revised its rules and regulations to address telehealth services. The Proposed Regulation defines telehealth as “the use of electronic communications to provide and deliver a host of health-related information and health care services, including occupational therapy related information and services, over electronic devices. Telehealth encompasses a variety of occupational therapy promotion activities, including consultation, education, reminders, interventions, and monitoring of interventions.”
The Proposed Regulation gives Occupational Therapist and Occupational Therapist Assistant licensees’ (Licensees) discretion in assessing and determining the appropriate level and type of care for an individual patient, provided that certain requirements are satisfied. Specifically, under the Proposed Regulation, Licensees that provide treatment through telehealth must have an active Delaware license in good standing to practice telehealth in the state of Delaware. In addition to obtaining informed consent and complying with confidentiality requirements, the licensee must also: (1) be responsible for determining and documenting that telehealth is an appropriate level of care for the patient; (2) comply with the Board’s rules and regulations and all current standards of care requirements applicable to onsite care; (3) limit the practice of telehealth to the area of competence in which proficiency has been gained through education, training and experience; (4) determine the need for the physical presence of an occupational therapy practitioner during any interactions with patients, if he/she is the Occupational Therapist who screens, evaluates, writes or implements the plan of care; (5) determine the amount and level of supervision needed during the telehealth encounter; and (6) document in the file or record which services were provided remotely. (24 Del. Admin. Code § 2000-4.2.)
Staff of the FTC’s Office of Policy Planning and its Bureaus of Competition and Economics, responding to the Board’s request for public comments, stated that by not imposing rigid and unwarranted in-person care and supervision requirements, the Proposed Regulation could have various positive impacts, including: (1) improving access to cost-effective, quality care, especially for patients with limited mobility; (2) reducing Medicaid’s transportation expenditures as well as individuals’ pecuniary and time costs; (3) addressing anticipated workforce shortages in the health care sector by increasing practitioner supply and facilitating care of an aging population; and (4) enhancing competition, consumer choice and access to [...]
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If you haven’t heard about newest gaming craze yet, it’s based on what is called “augmented reality” (AR) and it could potentially impinge on your home life and workplace as such games allow users to “photograph” imaginary items overlaid with objects existing in the real world. An augmented reality game differs from “virtual reality” in that it mixes elements of the real world with avatars, made up creatures, fanciful landscapes and the like, rather than simply presenting a completely fictional scenario. Whether you play such games yourself or are merely existing in nearby surroundings, here are few things to think about as an active participant, and some tips regarding Intellectual Property and confidentiality issues that arise from others playing the game around you.
Augmented reality games are typically played on a smartphone app and some of them allow the user to capture images of the player’s experience and post it on social media, text it to friends or maintain it on the phone’s camera roll. However, special glasses could be used or other vehicles could deliver the augmented reality experience in different contexts—not just gaming. For example, technology in this area is rapidly advancing which will allow users to link up and “experience” things together way beyond what exists in the real world, i.e., in a “mixed world” experience, if you will. These joint holographic experiences are just one facet of the direction that augmented reality is taking.
As always, with new technological advancements, there are some caveats to using AR that you should be aware of.
Trademarks
If a company’s trademark is visible in the photo of your AR experience, you need to be mindful that you do not run afoul of trademark laws. For the same reasons that some trademarks are blurred out on TV shows, you should not be publishing such photos in any fashion that might draw negative attention from the trademark owner on social media accounts. Even if you are not selling competing goods, you could potentially be liable for trademark infringement. There is another, more important reason not to post such photos that is discussed below and can lead to a second cause of action against you arising from the same photo—the right of publicity, which is a personal right and is treated in vastly different ways in each state.
Right of Publicity
The Right of Publicity (ROP) protects everyone from misappropriation of his/her name, likeness, voice, image or other recognizable element of personal identity. It is protected by state law and many states vary greatly in their treatment of ROP. For example, some states protect a person’s ROP post-mortem, whereas others have no protection whatsoever. Due to the ease with which still or moving images can be reproduced and posted on the Internet, it is critical that you consider your postings from a ROP standpoint before you upload that image to a social media account. For instance, if your photo features your best friend taken in a shared AR experience, she may not object [...]
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On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to the policies articulated in its January 2015 draft guidance. Notably, however, the Final Guidance added and refined several examples to illustrate the products that are subject to FDA’s enforcement discretion and ultimately outside FDA’s intended scope of regulatory oversight.
Read the full article, FDA Finalizes Guidance on Low Risk General Wellness Devices here.
The integration of technology into health care delivery is exploding throughout the health industry landscape. Commentators speculating on the implications of the information revolution’s penetration of the health care industry envision delivery models rivaling those imagined by celebrated science fiction authors, and claim that the integration of information technology into even the most basic health care delivery functions can reduce cost, increase access, improve quality and, in some instances, fundamentally change the way health care is delivered.
These visions are difficult to refute in the abstract; the technology exists or is being developed to achieve what just a few years ago seemed the idle speculation of futurists. But delivering this vision in an industry as regulated as health care is significantly harder than it may seem. While digital health models have existed for many years, the regulatory and reimbursement environment have stifled their evolution into fully integrated components of the health care delivery system.
New Ethical Guidelines
On June 13, the American Medical Association (AMA) adopted a new ethical guidance policy governing the practice of telemedicine that will be published in the coming months. The policy is based on a report from the AMA Council on Ethical and Judicial Affairs and builds upon the AMA’s 2014 telemedicine guidance.
Consistent with past guidance from AMA and other professional organizations, the AMA notes that the ethical responsibilities of physicians are the same – regardless of whether the physician communicates with a patient in-person or remotely – and encourages providers to recognize the potential uses and limitations of technology when delivering care. “Telehealth and telemedicine are another stage in the ongoing evolution of new models for the delivery of care and patient-physician interactions,” said AMA Board Member Jack Resneck, MD. “The new AMA ethical guidance notes that while new technologies and new models of care will continue to emerge, physicians’ fundamental ethical responsibilities do not change.”
The 2016 policy recommends that once a patient-physician relationship is established, physicians who engage in telemedicine by responding to individual health queries electronically or providing clinical services through telemedicine:
Notably, the 2014 guidance required that a patient-physician relationship be established prior to the provision of telemedicine services. The relationship could be established during a face-to-face examination, through a consultation with another physician, or by meeting the evidence-based practice guidelines developed by major medical specialty societies. While the 2014 guidance did not specify whether the face-to-face examination must occur in-person, rather than digitally, many interpreted this requirement to be satisfied via an interactive telemedicine encounter.
In addition, the 2016 policy formally recognizes the importance of a “coordinated effort across the profession,” which includes clarifying standards and promoting access to technology. That said, the 2016 policy still requires the licensure of physicians in the state in which the patient is located. (As a general rule, physicians that practice telemedicine are subject to the licensure rules of both the state in which their patient is physically located and the state in which the provider is practicing.) One potential avenue for facilitating multi-state licensure is the Federation of State Medical Boards’ Interstate Medical Licensure Compact, which offers a streamlined licensure process in each Compact state. The Compact has been adopted by 17 states thus far and more are expected to join this year and in 2017.
In sum, the AMA’s new ethical guidance should help physicians to better understand how their fundamental ethical responsibilities may play out differently when patient interactions occur through technology, and how this technology can [...]
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