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California is taking steps through Assembly Bill 254 (the “Bill”), approved by the State’s Governor on September 27, 2023, to ensure that patient information collected through reproductive or sexual health applications enjoys protections under the Confidentiality of Medical Information Act (the “CMIA”).[1] In addition to applying to providers and plans, the CMIA applies to businesses that offer software or hardware to consumers, such as mobile applications, which maintain medical information for the purpose of enabling management of such medical information or to otherwise support diagnosis, treatment, or management of a medical condition.[2] As a result, software and application developers may need to consider the CMIA with respect to their obligations relating to this particular data. In addition to certain confidentiality requirements, the CMIA also prohibits certain marketing uses and disclosures and requires breach notification in certain qualifying instances.Continue Reading California Moves to Protect Medical Information Collected Through Reproductive and Sexual Health Applications

The Florida Legislature recently amended the Florida Electronic Health Records Exchange Act (the “Act”) to prohibit certain health care providers utilizing certified electronic health record technologies from storing qualified electronic health records[1] outside of the United States, its territories, or Canada.[2] Significantly, the prohibition also extends to qualified electronic health records that are stored through a third-party or subcontracted computing facility or cloud service provider.[3]Continue Reading Florida Bans Offshoring of Certain Patient Information

On March 18, 2022, AdvaMed announced updates to the Code of Ethics on Interactions with Health Care Professionals (“Code”), a voluntary code that provides medical technology companies with guidance on ethically compliant interactions and relationships with healthcare professionals. The changes will take effect on June 30, 2022. The updates are part of a concerted effort by the medical device industry to respond to recent regulatory guidance and health industry trends. Below are 7 things that you need to know about these latest modifications.
Continue Reading 7 Things to Know About the New AdvaMed Code Updates