Search Results for: privacy

OCR Clarifies Direct Liability of Business Associates Under HIPAA

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new fact sheet outlining and clarifying violations of HIPAA (Health Insurance Portability and Accountability Act of 1996) for which a business associate can be held directly liable. Published shortly after the release of new guidance from OCR in the form … Continue Reading

CNIL Imposes Penalty to Optical Center; French Highest Administrative Court Reduces Amount

Life sciences companies doing business in France will be interested in the recent results of Optical Center’s appeal of a penalty assessed by the Commission nationale de l’informatique et des libertés, the French data protection authority, surrounding a data breach. The data breach allowed access to invoices and purchases containing personal and sensitive customer data. … Continue Reading

Health Apps and HIPAA – Recent FAQs Highlight Importance of Covered Entities and Business Associates Scrutinizing their Relationships with App Developers

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new set of HIPAA FAQs addressing the applicability of HIPAA to certain health apps and the covered entities and business associates that interact with them. These FAQs build upon prior guidance from OCR that outlined the framework for evaluating whether a … Continue Reading

Join Us for a Webinar on “GDPR: Live”

The Global Data Protection Regulation (GDPR), the new European data privacy regulation that will have world-wide reach, goes into effect on May 25, and will significantly affect life sciences companies. If you have been wondering what life is going to look like in a GDPR world, please join Reed Smith attorneys Cynthia O’Donoghue, Dr Andreas … Continue Reading

Join us for A Webinar on “Global Data Protection Regulation (GDPR) – Three Months to Go”

In three months, the new European data privacy regulation – with a world-wide reach and draconian sanctions for non-compliance – takes effect. Are you ready? Join Reed Smith on Thursday, February 22, 2018 for an informative CLE webinar discussing key priorities and strategies for compliance during the final three months remaining before the GDPR takes … Continue Reading

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices

FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information from devices with patients at the patients’ request. In response to the more active roles patients are playing in their health care, and increased frequency with which patients are seeking … Continue Reading

Upcoming Free CLE Webinar: “The Internet of Things’ Impact on the Health Care Industry: Diagnosing the Dangers with Disruptive Technology”

Reed Smith not only assists our pharmaceutical and medical device clients with their current legal challenges and opportunities, we look around corners to anticipate the next industry disruptor – and to help our clients navigate the legal issues that come with it. For our life sciences clients, the Internet of Things is clearly a game … Continue Reading

Reed Smith Launches Second Edition of 3D Printing White Paper

Following up the success of its first, medical device-focused 3D printing white paper, 3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles, Reed Smith’s 3D Printing Task Force has now launched a second edition of its 3D printing publication white paper addressing 3D printed products more broadly:  3D Printing of Manufactured Goods: … Continue Reading

What Brexit Means for Data Protection

For global pharmaceutical and medical device companies handling personal data in the European Union (EU) or engaged in transatlantic data transfers, some of the many questions created by the Brexit vote include what its impact will be on the United Kingdom’s (UK) data protection laws. These questions also arise in the context of the EU’s … Continue Reading

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