The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon monoxide breath sensor system” that measures carbon monoxide levels on a user’s breath. The sensor, which is intended to help users quit smoking, tracks the real time effects of a user’s smoking behavior. And just a few weeks ago, the FDA gave its approval to a cognitive behavioral therapy app to be used in outpatient therapy for substance use disorders related to alcohol, cocaine, marijuana and stimulants. Continue Reading Building a Health App? Part 4: Avoiding an FTC Enforcement Action
This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you with a basic understanding of FDA’s evolving approach to mobile apps so that you can make informed decisions about the legal consequences of your app’s functionality. Continue Reading Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps
This post is the second in a series of weekly blog posts covering legal issues for consideration during the early stages of development of a health app and providing best practices to help guide you through a successful launch. Consideration of intellectual property (IP) protection early in the development of a health app is important. Otherwise you could lose the opportunity to do so in the future or be forced to change the name or other details of your app after you have already invested time and money in the app.
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be able to analyze cardiac arrhythmia. According to one estimate, 165,000 health-related apps were available for Apple or Android smartphones last year. Forecasts predict that such apps will be downloaded 1.7 billion times by 2017. Without a doubt, health apps are turning into a big business presenting not only an opportunity for financial success but the potential to impact the health and wellness of millions of consumers. The success of a health app will depend on careful consideration of some key legal issues during the early stages of development. In a series of weekly blog posts, we will cover these issues and provide best practices to help guide you through the successful launch of your health app. Below is a preview of what this series will cover. Continue Reading Building a Health App? What You Need to Know
Last week, the Congressional Budget Office (CBO) concluded that a key piece of telehealth legislation, the CHRONIC Care Act of 2017, would not, overall, increase or decrease Medicare spending. This score is significant as it marks the first time that CBO has concluded that providing enhanced Medicare coverage for telehealth services would be budget neutral and clears the path for Congress to pass the legislation in a tough political climate. Continue Reading CBO Greenlights Telehealth Provisions in Senate’s CHRONIC Care Act
Although telehealth has the potential to improve or maintain quality of care for Medicare beneficiaries, payment and coverage restrictions create barriers that prevent providers from fully utilizing telehealth technologies. That is the core finding of a report issued by the Government Accountability Office (GAO) this month on telehealth and remote patient monitoring use for Medicare beneficiaries.
The GAO report was issued as part of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which included a provision for the GAO to study telehealth and remote patient monitoring. In compiling the report, the GAO interviewed representatives of nine provider, patient, and payor associations who provided feedback on, among other things, barriers to providing telehealth services to Medicare beneficiaries. Continue Reading GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption
In 2016 and now in early 2017, state legislatures and regulatory boards continue to enact laws and rules setting telemedicine practice standards. Such standards generally include clarifying the definition of telemedicine as well as providing standards related to prescribing in an online setting, patient informed consent, treatment of medical records generated during a telemedicine encounter, and confidentiality. A recent survey conducted by the Federation of State Medical Boards (FSMB) found that telemedicine standards are the number one priority for state medical boards going into 2017. Continue Reading States Continue Trend to Reduce Telemedicine Barriers
Earlier this week, the U.S. Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) filed an amicus brief with the Fifth Circuit stating that the Texas Medical Board’s (the “Board”) appeal was inappropriate and the Court does not have jurisdiction over the appeal. But the government did not stop there. The brief goes on to argue that if the Court does in fact find that it has jurisdiction, it should affirm the district court’s order denying the Board’s motion to dismiss and allow the case to proceed. Continue Reading Teladoc Receives Support from the Feds
Mintz Levin’s TCPA & Consumer Calling Practice team has issued its first monthly newsletter with legal updates and trends in this area. As we have pointed out before, the healthcare industry is not immune from litigation and enforcement based on the Telephone Consumer Protection Act (TCPA). Pharmacies and providers have been subject to settlement payments resulting from calls to consumers, and the FCC has addressed so-called “robocalls” made by healthcare providers in its rulings.
We are excited to present this inaugural Monthly TCPA Digest – Part I highlights TCPA Regulatory updates and considerations (including information about an FCC Public Notice seeking comment on a petition relating to the interaction between FCC rules and HIPAA), and then Part II explores TCPA Litigation developments. You can also learn more about our TCPA & Consumer Calling Practice from the newsletter.
With the continuing compliance challenges faced by health care industry participants and the overlay of sometimes competing regulatory frameworks, we hope this TCPA newsletter helps keep you informed of the risks and opportunities in this area. In an industry where timely and confidential communication is key, many providers and other industry participants are trying to navigate the legal landscape and keep an open line of communication with their patients and customers.
On June 17, the Texas Medical Board (“Board”) filed a brief with the Fifth Circuit Court of Appeals reiterating that the Board’s rulemaking processes are protected under the state action immunity doctrine, noting that the case could significantly impair state agencies in carrying out their governmental functions. The Board’s brief is the most recent action in the Teldoc case that has dragged on for almost two years and left little certainty for those who provide telemedicine services in the State.
As we previously reported, it all began when the Texas Medical Board issued an emergency proposed rule clarifying that physicians must perform a face-to-face or in-person physical examination of a patient prior to issuing a prescription or risk sanctions for unprofessional conduct. Teladoc, whose business model is based on providing health care services via telephone and without a face-to-face or in-person physical examination, sued the Texas Medical Board, alleging that the proposed rule violated antitrust laws. Late last year, a federal district court denied the Texas Medical Board’s motion to dismiss, finding that the Board is not entitled to state action immunity because its actions are not actively supervised by the state. Continue Reading Texas Medical Board Seeks State Action Immunity Protection in Fifth Circuit Brief