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.

As we start 2022, as part of our Spotlight series, we connect with Reece Hirsch, the co-head of Morgan Lewis’s privacy and cybersecurity practice, to discuss the recent policy statement issued by the US Federal Trade Commission regarding the Health Breach Notification Rule and how it applies to health app developers that handle consumers’ sensitive health information. Our Tech & Sourcing @ Morgan Lewis blog also published a summary of the policy statement.

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.

The German Federal Office for Information Security (BSI) has determined the suitability of an industry-specific security standard (B3S) with which hospitals can align their IT security measures. The B3S standard was developed by the German Hospital Association (DKG).

The Q2 2019 issue of Morgan Lewis’s Life Sciences International Review was recently released. The review includes updates relevant to the life sciences industry from across the world, including the United States, Europe, and Asia. The topics range from intellectual property and data privacy to international trade and labor and employment.