News & Analysis as of

Biotechnology Health Insurance Portability and Accountability Act (HIPAA)

Spilman Thomas & Battle, PLLC

Decoded Technology Law Insights, V 5, Issue 4, May 2024

MIT Report Details New Cybersecurity Risks - “Cloud misconfigurations, more sophisticated ransomware, and vendor exploitation attacks are contributing to rising cyberattacks.” Why this is important: Worldwide spending...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 4, Issue 7, August 2023

You may be Entitled to Financial Compensation…for Your Data - “Without all of our writings and photos that AI companies are using to train their models, they would have nothing to sell.” Why this is important: This...more

MoFo Life Sciences

Prevent A Clinical Trial From Turning Into A Criminal Trial

MoFo Life Sciences on

On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more

Quarles & Brady LLP

California Governor Signs the Genetic Information Privacy Act

Quarles & Brady LLP on

On October 6, 2021, California Governor Gavin Newsom signed into law the Genetic Information Privacy Act (GIPA). This follows Governor Newsom’s veto of an earlier version of the bill almost exactly one year ago. ...more

Womble Bond Dickinson

The Analysis of Cell Free DNA in Urine for Cancer Diagnosis – A Prospective Alternative to Liquid Biopsy?

Womble Bond Dickinson on

A promising new technology may make the diagnosis of cancer and genetic mutation testing as easy as performing a urinalysis as part of an annual physical exam.  Cancer could be detected at its earliest stages, when treatment...more

Womble Bond Dickinson

Privacy Risks Of Recreational DNA Testing: States Take Action

Womble Bond Dickinson on

Last week the California legislature passed an important first step in protecting the American public from itself. The Genetic Information Privacy Act (GIPA) helps fill a gap in U.S. healthcare privacy that most people don’t...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Summer 2019

Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices - Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG - The wearable device market is emerging as a key player...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Foley & Lardner LLP

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

Sheppard Mullin Richter & Hampton LLP

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

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