Area of focus

Digital Health

Technology is changing the way the health care industry operates. With changes come new challenges and opportunities — as well as a dramatic shift in the competitive and regulatory landscape. We bring a real-world sensibility to your challenges, helping you to remain competitive and compliant everywhere you operate. Our cross-jurisdictional team of more than 40 life sciences and health care lawyers with a focus on digital health take a technology-based approach to counseling on digital health products and...

Representative experience

Advising a leading pharmaceutical company in its digital health strategy in 21 jurisdictions.

Representing a high-technology company in connection with its life science business ventures, including exclusive licenses and joint ventures, to develop digital health products.

Advising several pharmaceutical and medical device companies on the regulatory status and the dissemination and marketing of mobile applications.

Advising a leading consumer product company on the development and classification of a consumer-oriented wearable sensor and associated mobile application.

Assisting a major diabetes manufacturer in seeking PMA approval for a sensor augmented insulin pump.

Advising on various regulatory aspects of international telemedicine, including cross-border healthcare, data privacy, and medical device aspects.

Advising a number of clients on the classification and regulation of software for communication between medical devices and physicians’/patients’ smartphones and agendas.

Advising a pharmaceutical company on compliance aspects, terms of use, and data privacy of a mobile health app for patients’ use.

Assisting a major pharmaceutical company with an enterprise-wide review of Telephone Consumer Protection Act compliance issues.

Advising a biopharmaceutical company on its agreement with a supplier of digital technologies (e.g., data capture solutions) for use in clinical trials.

Representing biotechnology company in administrative law proceedings related to financial penalty imposed by Ministry of Health concerning a mobile health app.

Assisting the German Federal Government in the IP clearance for the German e-health card.

Advising developers of wearable technology and digital health platforms on liability risk mitigation strategies.

Representing global technology company before EU national authorities in dispute with competitors concerning appropriate classification of software that supports a medical device.

Assisting medical device manufacturers with structuring their connected medical device services to facilitate cross-border data transfers and streamline EU data protection constraints.

Advising multiple global medical device manufacturers on the development of variations to existing medical devices for use in sports activities and/or a healthy lifestyle.

Co-authoring a study for the French CNIL on the regulation of connected health (“quantified self”) devices.

Hogan Lovells Publications

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are...

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Hogan Lovells Publications

Digital health: Understanding the new responsibilities facing life sciences companies related to collecting and processing personal health data under the GDPR

In May 2018, the General Data Protection Regulation (GDPR) entered into effect in EU member states, replacing a longstanding and less rigorous data and e-privacy directive. Not only does...

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Published Works

The FDA is innovating the approach to digital medical devices Digital Health Legal

By the time you read this article, it may well be outdated. And that's a good thing for digital health companies.

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Hogan Lovells Publications

Parsing products: FDA regulatory policy for multi-function medical devices Medical Device Alert

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...

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Blog Post

Boost for digital health in Germany – restrictions on remote treatment could be overturned in May 2018

At the next Annual General Meeting of the German Medical Association (Deutscher Ärztetag), the current restrictions on remote treatment by German physicians will most likely be...

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Hogan Lovells Publications

FDA releases working model for Software Precertification Pilot Program Medical Device Alert

Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its ...

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