On August 1, 2024, Colorado legislation took effect amending the mandatory disclosures that mental health providers must make to their clients under state law. Providers of mental health services in Colorado should take note...more
9/11/2024
/ Colorado ,
Compliance ,
Disclosure Requirements ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Mental Health ,
New Legislation ,
Patients ,
State and Local Government ,
State Legislatures
On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...more
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more
New state privacy laws regulating health data impose significant obligations and heightened risks. In addition to existing laws in California, Colorado and other states, Washington State’s My Health My Data Act and Nevada’s...more
3/4/2024
/ Benchmarking ,
Consumer Privacy Rights ,
Continuing Legal Education ,
Cookies ,
Data Privacy ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Information Technologies ,
New Legislation ,
PHI ,
State Privacy Laws ,
Tracking Systems ,
Webinars
On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more
11/1/2023
/ Artificial Intelligence ,
Biden Administration ,
Data Security ,
Executive Orders ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Legislative Agendas ,
New Legislation ,
New Regulations ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
9/6/2023
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Healthcare ,
Informed Consent ,
IRB ,
Life Sciences ,
Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Scientific Research
Remarkable progress in DNA and RNA sequencing have democratized the generation and analysis of genomic data across diverse industry sectors, including biopharmaceutical research, healthcare, consumer ancestry, law...more
Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more
Washington State’s My Health My Data Act (the Act), which is working its way through the reconciliation process after the Washington Senate and House passed different versions of the Act, is ultimately expected to be signed...more
4/14/2023
/ Carve Out Provisions ,
DATA Act ,
Data Controller ,
Enforcement ,
Exemptions ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Private Right of Action ,
State and Local Government ,
Washington
On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
On September 15, 2021, the Federal Trade Commission (FTC) voted 3–2 along party lines (with Republican commissioners dissenting) to issue a policy statement announcing an expansive interpretation of the FTC’s Health Breach...more
9/21/2021
/ Breach Notification Rule ,
Cybersecurity ,
Data Privacy ,
Data Security ,
Digital Health ,
Enforcement ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Mobile Health Apps ,
Personally Identifiable Information ,
PHI
On June 14, 2021, the US Court of Appeals for the 11th Circuit issued an order withholding issuance of the mandate for its April 21, 2021, holding in Hunstein v. Preferred Collection and Management Services, Inc. In Hunstein,...more
7/8/2021
/ Appeals ,
Consumer Protection Laws ,
Creditors ,
Debt Collection ,
Debt Collectors ,
Debtors ,
Disclosure ,
FDCPA ,
Personal Information ,
Relief Measures ,
Third-Party