Adriana Riviere-Badell and Alexandria Swette Examine Digital Health Regulation in Law360

September 8, 2021

Publication: Law360

The pandemic has accelerated the use of telehealth and digital health care services, attracting increased regulatory scrutiny and enforcement activity. However, the sector faces an uncertain, complex and still developing patchwork of laws and regulations in the U.S. and around the world. Kobre & Kim’s Adriana Riviere-Badell and Alexandria Swette, both of whom have deep experience in health fraud, survey the legal landscape in an article for Law360.

One issue in the U.S. involves the ongoing clash between protectionist state medical boards and the pro-competition Federal Trade Commission (FTC) over telehealth restrictions. Another issue is related to the ambiguous regulation of digital therapeutics by the U.S. Food and Drug Administration (FDA), where products such as health apps fall under uncertain jurisdiction.

Digital health services also face cross-border challenges. Globally, data privacy laws in the U.S. (both federally and in states such as California), the European Union and China have imposed various requirements on the growing amount of personal health data that is generated and collected. In addition, with the Organization of Economic Cooperation and Development (OECD) announcing a new proposed framework for international taxation, digital health services face an added source of uncertainty over how their profits might be taxed. 

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