On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
1/13/2025
/ Artificial Intelligence ,
Cybersecurity ,
Data Management ,
Data Protection ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Popular ,
Regulatory Requirements ,
Risk Assessment ,
Software
On December 1, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services provided guidance on the intersection of the Health Insurance Portability and Accountability Act (HIPAA) and the use of...more
With two recent enforcement actions, the Federal Trade Commission (FTC) has shown that administering appropriate data security policies is an area of priority. On October 24, 2022, the FTC announced a Proposed Consent Order...more
Your Organization’s best defense in an environment of aggressive regulators and litigious plaintiffs’ counsel is the completion of an enterprise risk assessment. Regulators and attorneys general are fining–sometimes hundreds...more
2/8/2019
/ Cybersecurity ,
Data Breach ,
Data Protection ,
Electronic Protected Health Information (ePHI) ,
Enterprise Risks ,
Hackers ,
HIPAA Breach ,
NIST ,
OCR ,
Personally Identifiable Information ,
Popular ,
Risk Assessment ,
Stakeholder Engagement
In its most recent cybersecurity initiative, the U.S. Department of Health and Human Services (HHS) has released Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients, described as a set of...more