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.
Breach of Contract Explained: Types and Consequences
Breach of contract disputes are the most common type of business litigation. Therefore, nearly all New York and New Jersey businesses will likely have to deal with a contract dispute at least once. Understanding when to file a breach of contract lawsuit and how long you have to sue for breach of contract is essential […]
How to Dissolve a Corporation in New Jersey: A Step-by-Step Guide
Closing your business can be a difficult and challenging task. For corporations, the process includes formal approval of the dissolution, winding up operations, resolving tax liabilities, and filing all required paperwork. Whether you need to understand how to dissolve a corporation in New York or New Jersey, it’s imperative to take all of the proper […]
Gross Lease vs. Net Lease: Understanding the Key Differences
Commercial leases can take a variety of forms, which is often confusing for both landlords and tenants. Understanding the different types, especially the gross lease structure, is important when selecting the lease that best suits your needs. One key distinction between lease types is how rent is calculated and paid. This article addresses the two […]
What to Do If You Are Impacted by a Retailer Bankruptcy Part 2
Over the past year, brick-and-mortar stores have closed their doors at a record pace. Fluctuating consumer preferences, the rise of online shopping platforms, and ongoing economic uncertainty continue to put pressure on the retail industry. When a retailer seeks bankruptcy protection, a myriad of other businesses are often impacted. Whether you are a supplier, customer, […]
The Current Administration's Proposals for the Financial Services and Banking Industries Will Affect Your Business
Since his inauguration two months ago, Donald Trump’s administration and the Congress it controls have indicated important upcoming policy changes. These changes will impact financial services policies and priorities. The changes will particularly affect cryptocurrency, as well as banking rules and regulations. Key Regulatory Changes in Cryptocurrency For example, in the burgeoning cryptocurrency business environment, […]
Tips for Commercial Landlords Impacted by Wave of Retailer Bankruptcies Part 1
The retail sector has experienced a wave of bankruptcy filings over the last year. Brick-and-mortar businesses in financial distress include big-name brands like Big Lots, Party City, The Container Store, and Vitamin Shoppe. When large retailers seek bankruptcy protection, they are not the only businesses impacted. Landlords can be particularly hard hit. While commercial landlords […]
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!
