Many digital health app developers offering health and wellness solutions directly to consumers may find themselves in a space unregulated by the Health Insurance Portability and Accountability Act (“HIPAA”). While potentially outside the scope of HIPAA, developers in this space are reminded of the risks stemming from other federal and state privacy and security laws, including unfair or deceptive abuse acts and practices (UDAAP) laws. A recent Federal Trade Commission (“FTC”) settlement sheds light on the importance of accurately describing how information is collected, used, and shared.
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FTC Targets Reporting of Licensing of Pharmaceutical Patents With Special Rules for Premerger Notification: What You Need to Know
On November 15, 2013, the Federal Trade Commission (“FTC”) adopted special rules for determining whether “exclusive” licenses of pharmaceutical patents are required to be reported to the FTC and the Antitrust Division of the Department of Justice under the Hart-Scott-Rodino Premerger Notification requirements as asset transfers/acquisitions. See 78 Fed. Reg. 68705, et seq. While exclusive licenses of any patent regardless of industry have always been subject to reporting under the Premerger Notification rules as asset transfers/acquisitions, assuming they met the monetary thresholds for reporting, the FTC, adopted new rules specifically targeting exclusive licenses of patents of pharmaceutical companies.
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