Data and privacy · Data protection and privacy laws
Our use and disclosure of personal information, including health information, is subject to federal, state and foreign privacy, artificial intelligence, data, biometrics and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could result in significant liability, regulatory investigations, legal actions, or reputational harm.
Industry regulation · Fda drug and device approval
Product sales, introductions or modifications may be delayed or canceled as a result of FDA regulations or similar foreign regulations, which could cause our sales and profits to decline...Before we can market or sell a new medical device in the U.S., we must obtain FDA clearance or approval, which can be a lengthy and time-consuming process.
Legal and litigation · Litigation and legal proceedings
We are subject to potential professional services liability claims due to our recent acquisition of VirtuOx, which may exceed the scope and amount of our insurance coverage, which would expose us to liability for uninsured claims.
Tax and financial reporting · Tax compliance and changes in tax law
Income tax laws, regulations, and enforcement practices in various jurisdictions are evolving and, as a result, tax authorities are aggressively pursuing taxpayers. This may result in expense as well as management distraction, which may result in a material adverse effect on our results of operations, cash flows and financial position.