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In seeking to identify business costs and risks, and to subsequently mitigate them to the fullest extent possible to ensure continued viability and profit, companies in Ohio and nationally basically conduct nonstop due diligence and brainstorming.

For some enterprises, lean, hungry and constantly emerging competitors are a key concern. Others focus constantly on staying ahead of the curve regarding what consumers want. Many businesses are unwaveringly fixated on maintaining a reliable supply stream of necessary resources and goods at competitive prices.

And, of course, legions of companies are focused on all those matters, all the time, and on myriad additional concerns as well.

For many participants in the health care industry, one such added concern routinely comes to the fore, namely, regulatory compliance.

Regulators in the health care realm are many and exacting, and companies in the industry have to deal with many requirements. Officials with the U.S. Food and Drug Administration, for example, exercise close and constant oversight regarding matters such as product safety, labeling requirements and testing protocols. The U.S. Federal Trade Commission routinely acts in matters it deems affect consumers and the public interest. And many states -- including Ohio -- impose additional layers of regulatory oversight on health care actors.

One recent media report discussing a health industry settlement notes the heightened scrutiny that so-called "health app developers" are receiving from regulators in terms of what their products say and allegedly do (or don't turn out to do), how they are labeled, what disclaimers they include and so forth.

Another point made in that article stresses that digital health products (again, primarily offerings such as services available through Internet applications) might now be entering a new phase of expanded compliance necessitated by demands from attorneys general across the country.

Although the report cites only the New York AG's involvement in the above-cited settlement, it adds that the matter could be significant in that the involvement could now induce AGs in other states "to step up and take similar action against digital health companies."

Regulatory compliance is obviously a big issue for companies of all sizes and types. Business principals with questions or concerns regarding regulatory matters might reasonably turn to a proven business and commercial law firm with a demonstrated record of client advocacy in this complex legal realm.

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Gottschlich & Portune, LLP
201 East Sixth Street
Dayton, OH 45402

Phone: 937-802-2397
Phone: 937-802-2397
Fax: 937-824-2818
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