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Things to Consider When Determining the Regulatory Requirements for Software (Hint: It’s More Than the Device Classification)
October 4, 2023 | Blog | By Benjamin Zegarelli
The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are developing software aimed at health care systems, hospitals, physicians, and lay-users for various levels of use, from assisting diagnoses in a clinical environment to tracking exercise and general health indicators in the home. In particular, a growing number of companies is focusing on the development of digital therapeutics - a class of software devices that deliver and monitor medical interventions for the purpose of treating, managing, or preventing certain diseases or conditions - for use in a patient’s home. With all of the new players jumping into the digital health technology game, we thought it might be useful to provide a brief primer on certain factors to consider when evaluating the potential regulatory requirements for such products.
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Building a Health App? Part 7: Commercialization and Strategic Partners
November 1, 2017 | Blog | By Julie Korostoff
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.
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Building a Health App? Part 6: HIPAA and Other Privacy and Security Considerations
October 25, 2017 | Blog | By Dianne Bourque
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.
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Building a Health App? Part 5: Contracting for Health App Construction
October 18, 2017 | Blog | By Julie Korostoff
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.
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Building a Health App? Part 4: Avoiding an FTC Enforcement Action
October 10, 2017| Blog|
Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps
October 3, 2017 | Blog | By Benjamin Zegarelli
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.
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Building a Health App? Part 2: Protecting Your Intellectual Property
September 25, 2017 | Blog | By Christina Sperry
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.
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Building a Health App? What You Need to Know
September 18, 2017| Blog|
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