Given the uncertainty in reimbursement from private insurance and government programs such as Medicare and Medicaid, it is important early on to consider how best to land and leverage relationships with key customers and strategic partners. As a start-up company, getting a strategic deal with a name-brand company is an excellent means to validate your technology. How do you take advantage of that opportunity, but not give away too much? This final installment in our blog series will suggest some best practices for negotiating these early stage strategic relationships. Continue Reading Building a Health App? Part 7: Commercialization and Strategic Partners
Consumers are increasingly turning to health apps for a variety of medical and wellness-related purposes. This has in turn caused greater amounts of data—including highly sensitive information—to flow through these apps. These data troves can trigger significant compliance responsibilities for the app developer, along with significant legal and contractual risk. This latest installment in our health app series will introduce some of these considerations, including approaches that developers can take to minimize their risk. Continue Reading Building a Health App? Part 6: HIPAA and Other Privacy and Security Considerations
As you take your health app from innovative idea to reality, you will be engaging in a development project that will likely entail the procurement of technology, services and perhaps even content from third parties. For example, you may hire an app developer. Or perhaps you will take advantage of a cloud-based hosting platform that enables you to build a secure health app leveraging a third party’s infrastructure, such as Amazon or Google. Perhaps your app will integrate patient education content from a medical publisher or rely on analytics from an industry data aggregator. Careful contracting with third parties who provide these services and components will be critical to your health app’s success. This fifth installment of our series will outline contracting principles for the construction of a health app. Continue Reading Building a Health App? Part 5: Contracting for Health App Construction
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