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

Artificial Intelligence and your business: A guide for navigating the legal, policy, commercial, and strategic challenges ahead

Virtually all industries are being reshaped with the use of Artificial Intelligence and advanced machine-learning.

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Hogan Lovells Publications

Expanded coverage of telehealth

The recently enacted Bipartisan Budget Act of 2018 expands Medicare’s coverage for telehealth services in several ways. Inclusion of these provisions, which had been part of a Senate...

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Hogan Lovells Publications

Digital Health: The issues you need to consider to leverage its full potential in 2018

Technology is changing the way the healthcare industry operates, bringing huge potential for untapped business opportunity. At the same time, with these changes comes a dramatic shift in...

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Hogan Lovells Publications

FDA unveils software pre-certification pilot program to foster digital health innovation

Following promises in June for a new regulatory paradigm to address regulation of medical software, FDA released a Digital Health Innovation Action Plan on July 27, 2017, including a pilot...

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Hogan Lovells Publications

Gottlieb Announces New Regulatory Paradigm for Digital Health Software

The rapid development of medical software products continues to create regulatory challenges for the Food and Drug Administration (FDA).

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Hogan Lovells Publications

On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and...

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