Mobile healthcare apps are big business. An estimated 500 million smartphone users worldwide will be using them by 2015.
In response to the growing industry, the U.S. Food and Drug Administration (FDA) recently released its plan to regulate medical healthcare apps.
The new rules will not impact tools that allow you to look up the symptoms of the flu or track your weight loss goals from the convenience of your smartphone. Rather, they will focus exclusively on healthcare apps that function as medical devices.
According to the FDA, the agency will apply the same risk-based approach it uses to assure safety and effectiveness for other medical devices. However, many apps will not fall under the purview of the new regulations. The FDA will only regulate mobile apps that meet the regulatory definition of “device” and that:
Are intended to be used as an accessory to a regulated medical device, or
Transform a mobile platform into a regulated medical device.
The FDA also intends to exercise enforcement discretion over certain mobile applications that satisfy the regulatory definition of a “device” but pose minimal risk to patients and consumers. Examples include apps that: help patients self-manage a condition without providing specific treatment suggestions; provide patients with simple tools to organize and track their health information; and enable patients and providers to interact with electronic health record systems. Manufacturers of these mobile apps will not be required to undergo the premarket review process or register their apps with the FDA.
The FDA’s decision is good news for the medical technology industry. Given the prior lack of clarity on how the agency would regulate apps, many companies had delayed plans to jump into the action. And, given the popularity of apps, it is also good news for us patients.
If you have any questions about the FDA policy or would like to discuss the legal issues involved, please contact me, Dan Brecher, or the Scarinci Hollenbeck attorney with whom you work.
Special purpose acquisition companies (better known as SPACs) appear to be making a comeback. SPAC offerings for 2025 have already nearly surpassed last year’s totals, with additional transactions in the pipeline. SPACs last experienced a boom between 2020–2021, with approximately 600 U.S. companies raising a record $163 billion in 2021. Notable companies that went public […]
Short Form Merger: Streamlining the Process for Businesses
Merging two companies is a complex legal and business transaction. A short form merger, in which an acquiring company merges with a subsidiary corporation, offers a more streamlined process that involves important corporate governance considerations. A short form merger, in which an acquiring company merges with a subsidiary corporation, offers a more streamlined process. However, […]
Tariff Response Options for Small Businesses Facing Financial Distress
The Trump Administration’s new tariffs are having an oversized impact on small businesses, which already tend to operate on razor thin margins. Many businesses have been forced to raise prices, find new suppliers, lay off staff, and delay growth plans. For businesses facing even more dire financial circumstances, there are additional tariff response options, including […]
Common Causes of Partnership Disputes and How to Resolve Them
Business partnerships, much like marriages, function exceptionally well when partners are aligned but can become challenging when disagreements arise. Partnership disputes often stem from conflicts over business strategy, financial management, and unclear role definitions among partners. Understanding Business Partnership Conflicts Partnership conflicts place significant stress on businesses, making proactive measures essential. Partnerships should establish detailed […]
Businesses Are Facing Financial Headwinds—A Practical Guide
*** The original article was featured on Bloomberg Tax, April 28, 2025 — As a tax attorney who spends much of my time helping people and companies who have large, unresolved issues with the IRS or one or more state tax departments, it often occurs to me that the best service that I can provide […]
President Trump's Termination of Member Gwynne Wilcox
On January 28, 2025, the Trump Administration terminated Gwynne Wilcox from her position as a Member of the National Labor Relations Board (NLRB or the Board). Gwynne Wilcox, a union side lawyer for Levy Ratner, was confirmed to the Board for an original term in 2021 and confirmed again for a successive five-year term expiring […]
No Aspect of the advertisement has been approved by the Supreme Court. Results may vary depending on your particular facts and legal circumstances.
Sign up to get the latest from our attorneys!
Explore What Matters Most to You.
Consider subscribing to our Firm Insights mailing list by clicking the button below so you can keep up to date with the firm`s latest articles covering various legal topics.
Stay informed and inspired with the latest updates, insights, and events from Scarinci Hollenbeck. Our resource library provides valuable content across a range of categories to keep you connected and ahead of the curve.
Let`s get in touch!
Sign up to get the latest from the Scarinci Hollenbeck, LLC attorneys!
