News & Analysis as of

Medical Devices Data-Sharing

Womble Bond Dickinson

Automated External Defibrillators: An Untapped Source of Medical Records?

Womble Bond Dickinson on

An estimated 350,000 out-of-hospital cardiac arrest deaths occur each year in the U.S. Approximately 10% of those who experience out-of-hospital cardiac events survive. Use of automated external defibrillators (AED), however,...more

Hogan Lovells

EU Data Act Series (part 3): medical and health devices and data sharing obligations

Hogan Lovells on

The Data Act Proposal envisages the rights of users of medical devices / health wearables to have access to and to share the data originated from the use of the device with third parties. These access and sharing rights are...more

Morgan Lewis - Tech & Sourcing

Metaverse Health: A Chance to Respawn Data Interoperability, Privacy, and Security

As we all try to keep up with the Metaverse and as the healthcare system wilts under a data deluge, the convergence of realities in a shared online space is not merely a chance for practitioners and patients to find each...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Bricker Graydon LLP

COVID-19 Update: Data sharing requests and orders for hospitals

Bricker Graydon LLP on

Recently, health care providers – in particular hospitals – have been requested by the federal government to share data related to the treatment of COVID-19 (coronavirus) patients and have been ordered by the Ohio Department...more

Knobbe Martens

FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring

Knobbe Martens on

The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new...more

Troutman Pepper

FDA's Expanding Views on Cybersecurity and Medical Devices: Draft Guidance on Postmarket Management of Cybersecurity

Troutman Pepper on

Medical device manufacturers need to consider cybersecurity controls in all aspects of the product development process, from conception through commercialization. In response to concerns about increased cybersecurity...more

Knobbe Martens

Medical Device Clinical Trial Data from Johnson & Johnson To Be Made Available

Knobbe Martens on

According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time.  The Yale University Open Data Access (“YODA”)...more

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