Last week, the United States Congress passed the $280 billion CHIPS and Science Act of 2022 (CHIPS Act)[1] to bolster domestic semiconductor and microchip manufacturing in the United States. The bipartisan legislation will facilitate federal investments in the form of grants, loans, and loan guarantees to eligible entities and create significant business opportunities for
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FTC Updates (June 13-17, 2022)
This week, the Commission announced that it blocked a hospital merger in Utah and New Jersey and ordered an oil and gas divestiture in Michigan. The FTC also issued a policy statement on exclusionary rebates and fees in prescription drug pricing and submitted a report to Congress on combatting online harms through innovation. Commissioner Noah
Proposed European Health Data Space Regulation
On May 3, 2022, the European Commission published a proposed regulation (the “EHDS Proposal”) for the establishment of a European Health Data Space (or “EHDS”). This is the first proposal for establishing domain-specific common European data spaces following the European strategy for data and an important step in building a European “Health Union”.
In short, the
California AG Interprets “Inferences” Under CCPA
The California Office of the Attorney General issued its first opinion interpreting the California Consumer Privacy Act (CCPA) on March 10, 2022, addressing the issue of whether a consumer has a right to know the inferences that a business holds about the consumer. The AG concluded that, unless a statutory exception applies, internally generated inferences that
FDA Publishes Principles for AI and ML in Medical Devices
On October 27, 2021, the U.S. Food and Drug Administration (FDA) in collaboration with Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), published Guiding Principles for the use of artificial intelligence and machine learning (AI/ML) in medical devices. The principles are designed to support good machine learning practices (GMLP) and to
Biden’s First 100 Days: Developments to Date and What Lies Ahead
A Crowell & Moring Overview of the Biden Administration’s First 100 Days in Office
After 100 days in office, President Joe Biden has made it clear that he is not afraid to go it alone to pursue policy to match his campaign rhetoric and promises. The first 100 days of the administration were marked by
Recent Changes in Chinese Export Controls: Are Your China Operations Ready?
For the first time in nearly two decades, China is revamping its export control regime and issuing its first unified Export Control Law, which combines concepts from more than a dozen existing Chinese laws and related regulations. This alert summarizes the most significant changes from current Chinese export control practice, highlights what may be included in
ICPHSO International Symposium Panel on GDPR and the EU’s Digital Single Market
On November 12, Crowell & Moring chaired a plenary session during the 2018 ICPHSO International Symposium in Brussels, which was presented as part of the European Commission’s International Product Safety Week. The panel focused on how, as a result of their Big Data strategies, Business-to-Business (“B2B”) companies are
Closing the Health Information Privacy Divide
- More of our health information is becoming digital every day, as new technology companies enter the health care and wellness markets.
- Many companies that hold a wealth of consumer health information are not covered by HIPAA.
- Many consumers may not realize that their health information only is protected and they only have certain rights
Plugging the “Gaps” on Transfers of U.S. Sensitive Emerging Technology: Dual-Use Export Control Statutory Authority Becomes Law
The Export Control Reform Act of 2018, included within the National Defense Authorization Act (NDAA) for Fiscal Year 2019, became law on August 13, 2018, and provides “modern” and permanent statutory authority for the U.S. Export Administration regulations (EAR), which control the export, re-export, and transfer of U.S. origin “dual-use” items.
As a result of