On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
9/6/2023
/ Clinical Trials ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Informed Consent ,
IRB ,
Life Sciences ,
Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Scientific Research
On July 10, 2023, the European Commission (“Commission”), which oversees and implements policies and laws of the European Union (“EU”), adopted an adequacy decision for the long-awaited EU-U.S. Data Privacy Framework...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more
Ransomware Particularly Inflicts Health Care and Life Sciences Organizations -
Ransomware is a malicious cyber threat vector that employs encryption malware to prevent users from accessing their systems and data unless...more
6/3/2021
/ Cyber Attacks ,
Cyber Crimes ,
Cybersecurity ,
Data Breach ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
FBI ,
Hackers ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Technology ,
Malware ,
Medical Records ,
Personally Identifiable Information ,
Popular ,
Ransomware ,
Risk Management