Why Venture Capital Investors Are Focused on Femtech

Andrew Harper in San Francisco and Francesca Blythe in London look at some of the drivers that are fueling interest in digital health products aimed at women.

The term ‘Femtech’ was coined by the founder of a fertility app company in response to her experience that male investors often struggle with the specifics of discussing products focused on women’s reproductive health. However, Femtech covers a wider range of products than the purely fertility-focused, including all health software and tech-enabled products that cater to female biological needs and to the wider wellness market for all those who identify as women.

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If Your Company Is GDPR Compliant, Are You Ready for China’s PIPL?

China’s first dedicated law on personal data protection comes into effect this month. Sidley counsel Jing Lu looks at how the new Personal Information Protection Law (PIPL) differs from Europe’s General Data Protection Regulation (GDPR).

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U.S. Looks to Introduce European-Style Drug Price Controls

Meena Datta examines proposed new legislation that would authorise the Health and Human Services Secretary to negotiate prices directly with prescription drug manufacturers.

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Regulators Offer Fresh Guidance on Using Real-World Data to Support Regulatory Decisions

Becky Wood in Washington, D.C., Emily Marden in Palo Alto, and Josefine Sommer in Brussels look at new FDA guidance on the use of real-world data to support new indications and post-approval study requirements.

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How Artificial Intelligence Manufacturers Can Protect Themselves Against Future Negligence Claims

Elizabeth Curtin in Chicago and Jonathan Tomlin in London consider why any litigation arising over medtech that uses AI is likely to become complex. They consider how manufacturers of AI can support physicians’ medical judgments and help guard against the danger that they might themselves inadvertently become ‘insurers’ of medical outcomes.

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What Do the FDA’s Expanded ‘Intended Use’ Regulations Mean for Safe-harbored Communications about New Uses?

Prior to their webinar on Thursday, October 7, Coleen Klasmeier and Jaime Jones consider some of the effects of the final rule.

FDA’s final rule to amend its medical product ‘intended use’ regulations has now been in effect  since September 1. The changes which the final rule makes to the definition of intended use, as interpreted by FDA in the accompanying preambles, expand the types of evidence that are deemed relevant to determining whether a lawfully marketed drug or device has a new intended use and whether a product is intended for use as a drug or device.

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Pharmacovigilance Considerations in the Era of Patient Centricity: Data Collected by Apps

On World Patient Safety Day, Torrey Cope in Washington, D.C., Chen Yang in Beijing, and Olivier Goarnisson in Geneva consider one big pharmacovigilance question raised by the increasingly patient-centric way in which life science companies are doing business today: How to treat the data collected by the apps provided with drugs and devices.

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