McKinsey’s Global HealthTech Network
McKinsey's Global HealthTech Network, a network of more than 300 digital-healthcare start-ups, is hosting their 1st Health Tech CEO Connect for 2021 on the regulatory and legal side of Software as a Medical Device (SaMD) in the US and EU with Bethany Hills and Wolfgang Schoenig from Morrison & Foerster and several digital health guest speakers, including Pear Therapeutics.
Software as a Medical Device (SaMD) is a category of health technology gaining more momentum commercially, and with that, more focus from regulators. The US FDA has maintained a fairly focused effort on establishing a regulatory framework for SaMD over the past number of years, beginning with guidance for mobile medical apps, general wellness products, establishment of a pre-certification program for digital health software, proposals for artificial intelligence/machine learning in medical device software and, most recently, the establishment of the Digital Health Center of Excellence within FDA. EU regulators have also been focused on improved regulatory oversight, starting with the IMDRF recommendations on risk characterization from 2014, the enactment of the new Medical Device Regulation that significantly changes the classification assessment for SaMD, and recent guidance documents such as the Medical Device Coordination Group Document MDCG 2019-11.
Both the US and the EU regulators have also taken a renewed focus on cybersecurity issues.
In this CEO Connect, they explore key foundations in this topics across the US and the EU, and focus on the following digital health use cases: digital therapeutics, consumer facing wearables and apps, clinical decision support functions and AI/ML driven SaMD.