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.
When Are New Jersey Business Owners Personally Liable for Corporate Debt?
New Jersey personal guaranty liability is a critical issue for business owners who regularly sign contracts on behalf of their companies. A recent New Jersey Supreme Court decision provides valuable guidance on when a business owner can be held personally responsible for a company’s debt. Under the Court’s decision in Extech Building Materials, Inc. v. […]
Commercial real estate trends in 2026 are being shaped by shifting economic conditions, technological innovation, and evolving tenant demands. As the market adjusts to changing interest rates, capital flows, and workplace models, investors, owners, tenants, and developers must understand how these trends are influencing opportunities and risk in the year ahead. Overall Outlook for Commercial […]
One Big Beautiful Bill: New Tip Income Tax Rules Employers & Workers Need to Know
Part 2 – Tips Excluded from Income Certain employees and independent contractors may be eligible to deduct tips from their income for tax years 2025 through 2028 under provisions included in the One Big Beautiful Bill. The deduction is capped at $25,000 per year and begins to phase out at $150,000 of modified adjusted gross […]
One Big Beautiful Bill: New Overtime Tax Rules Employers and Employees Need to Know
Part 1 – Overtime Pay and Income Tax Treatment Overview This Firm Insights post summarizes one provision of the “One Big Beautiful Bill” related to the tax treatment of overtime compensation and related employer wage reporting obligations. Overtime Pay and Employee Tax Treatment The Fair Labor Standards Act (FLSA) generally requires that overtime be paid […]
New York’s FAIR Business Practices Act: What the New Consumer Protection Measure Means for Your Business
In 2025, New York enacted one of the most consequential updates to its consumer protection framework in decades. The Fostering Affordability and Integrity through Reasonable Business Practices Act (FAIR Act) significantly expands the scope and strength of New York’s long-standing consumer protection statute, General Business Law § 349, and alters the compliance landscape for New York […]
How to Reduce Legal Risk as Your New Jersey Business Grows in 2026
For many New Jersey businesses, growth is a primary objective for the New Year. However, it is important to recognize that growth involves both opportunity and risk. For example, business expansion often results in complex contracts, an increased workforce, new regulatory requirements, and heightened exposure to disputes. Without proactive planning, even routine growth can lead […]
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!
