Tech & Sourcing @ Morgan Lewis

The US Cybersecurity and Infrastructure Security Agency (CISA) has recently released draft rules that are set to reshape how critical infrastructure companies report cyberattacks to the US government. The rules are designed to improve the country's cybersecurity by making sure cyber incidents are reported quickly and thoroughly. This could help create a clearer understanding of cyber threats and may mitigate against future cyberattacks.

Emily Lowe and Ben Klaber recently presented a webinar on key contracting considerations in life sciences supply chain and manufacturing transactions as part of Morgan Lewis’ ongoing Digital Disruption and Innovation webinar series.

According to recent guidance from the US Federal Trade Commission (FTC), providers of health apps and connected devices that collect consumers’ health information must comply with the FTC’s Health Breach Notification Rule, 16 CFR Part 318, and therefore are required to notify consumers and others when their health data is breached.

As the availability and variety of digital health tools continue to increase, evidence is also being presented that those tools are having a meaningful impact on health outcomes. A recent report, Digital Health Trends 2021: Innovation, Evidence, Regulation, and Adoption, offered by the IQVIA Institute for Human Data Science, looks at the proliferation of digital health tools, recent innovations in the market, and contributions and barriers to their adoption.

Companies developing digital therapeutics, clinical decision support apps, and other digital health technologies for use in the coronavirus (COVID-19) pandemic should be mindful of FDA’s quickly evolving policies and guidance affecting such technologies. In our recent LawFlash, FDA Regulation of COVID-19 Apps, Digital Therapeutics, and other Digital Health Technologies, we examine recent FDA developments and their implications for companies in the digital health space.