On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
2/24/2025
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Data Management ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Healthcare ,
Labeling ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management ,
Technology
On December 16, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
How would a Harris-Walz administration affect clients in your practice?
Bottom line: It would likely put to rest or delay debates about the Affordable Care Act (ACA), allowing health policy and legislation to focus on other...more
10/22/2024
/ Affordable Care Act ,
Cybersecurity ,
Donald Trump ,
Federal Trade Commission (FTC) ,
Health Insurance ,
Healthcare ,
Kamala Harris ,
Political Campaigns ,
Political Candidates ,
Popular ,
Presidential Elections ,
Privacy Laws ,
Proposed Legislation ,
Proposed Regulation
The Texas Attorney General (AG) recently announced a “first-of-its-kind” settlement with a healthcare generative artificial intelligence (AI) company, Pieces Technologies, Inc., resolving allegations that the company made a...more
On August 5, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
During this session, the panelists discussed how stakeholders in the clinical research market can leverage new technologies to better identify subjects, optimize trial conduct and reduce costs. For example, common use cases...more
In a consequential decision for Health Insurance Portability and Accountability Act (HIPAA)-regulated entities, on June 20, 2024, the US District Court for the Northern District of Texas ruled in American Hospital Association...more
On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a complement and counterpart to the breach notification requirements...more
5/29/2024
/ American Recovery and Reinvestment Act ,
Breach Notification Rule ,
Electronic Health Record Incentives ,
Federal Trade Commission (FTC) ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Mobile Apps ,
Notification Requirements ,
PHI ,
Popular
Following the White House’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, on December 13, 2023, the White House announced that 28 healthcare payors and providers intend...more
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
Data governance is a mission-critical issue for every company and institution in the United States.
GCs face a host of pressing cybersecurity concerns. Triaging them requires time, attention, and a well-rounded strategy...more
8/18/2023
/ Cookies ,
Corporate Governance ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Disclosure Requirements ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
Legislative Agendas ,
Mobile Apps ,
New Legislation ,
New Rules ,
OCR ,
Personal Information ,
Regulatory Agenda ,
Risk Factors ,
Risk Management ,
State Privacy Laws ,
Technology Sector ,
Tracking Systems
In this session, panelists discussed common pitfalls that life sciences companies face as they explore ways to incorporate digital-health strategies into product and service offerings, as well as approaches for successful...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
On December 10, 2020, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM) with proposed modifications to the Standards for the Privacy of...more
12/18/2020
/ Department of Health and Human Services (HHS) ,
Disclosure ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Access Request ,
HIPAA Privacy Rule ,
Information Requests ,
Medicare ,
NPRM ,
OCR ,
Third-Party
The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how care is delivered, to lower healthcare costs, and to improve healthcare...more
12/19/2019
/ Data Management ,
Data Privacy ,
Digital Health ,
Disruptive Technology ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Innovation ,
Medical Devices ,
Regulatory Burden
President Obama signed the 21st Century Cures Act on December 13, 2016. The act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide...more
In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more
On March 16, 2015, the Newborn Screening Saves Lives Reauthorization Act of 2014 went into effect. The Act reauthorizes funding to improve and expand state-based programs that screen newborns for treatable, serious genetic...more
As we reported in May 2014, the Federal Trade Commission (FTC) convened stakeholders to explore whether health-related information collected from and about consumers — known as consumer-generated health information (CHI) —...more
What privacy, advertising and digital media trends will make headlines in 2015? Digital Health for one, Big Data for another....more
On May 1, 2014, the White House released two reports addressing the public policy implications of the proliferation of big data. The first report is by the Executive Office of the President, entitled “Big Data: Seizing...more
5/13/2014
/ Barack Obama ,
Big Data ,
Data Breach ,
Data Protection ,
ECPA ,
Healthcare ,
Legislative Agendas ,
Life Sciences ,
Privacy Laws ,
Privacy Policy ,
Public Policy
Office of Civil Rights has released additional guidance addressing the de-identification of protected health information in accordance with the HIPAA Privacy Rule. Covered entities should review their current...more