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
On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press release, fact sheet, FAQs) reinterpreting Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the...more
5/9/2024
/ Affordable Care Act ,
Department of Health and Human Services (HHS) ,
Disability Discrimination ,
Final Rules ,
Gender Discrimination ,
Gender Identity ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicare Part B ,
New Regulations ,
Non-Discrimination Rules ,
Race Discrimination ,
Section 1557 ,
Sexual Orientation Discrimination
The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more
4/10/2024
/ Algorithms ,
Artificial Intelligence ,
Certification Requirements ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Information Technologies ,
Healthcare ,
Information Technology ,
ONC ,
Risk Management ,
Technology
On February 8, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) jointly issued a final rule to amend the...more
On January 17, 2024, the New York State Department of Financial Services (NYDFS) issued a proposed Circular Letter that provides guidance for authorized insurers using external consumer data and information sources (ECDIS)...more
On December 13, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued the Health Data, Technology, and Interoperability: Certification...more
On December 13, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued the Health Data, Technology, and Interoperability: Certification...more
The California legislature has created a lot of holiday homework for California healthcare providers, passing more than 50 new laws regulating a wide range of healthcare providers and healthcare business operations that apply...more
Substantial changes to the California Consumer Privacy Act (CCPA) are coming soon through five sets of proposed regulations governing (1) cybersecurity audits, (2) privacy risk assessments, (3) artificial...more
In the wake of the Supreme Court of the United States’s decision in Dobbs v. Jackson Women’s Health Organization and the adoption of laws outside California that criminalize most abortions as well as gender affirming care,...more
11/20/2023
/ Abortion ,
Adoption ,
California ,
Digital Health ,
Dobbs v. Jackson Women’s Health Organization ,
Electronic Medical Records ,
Healthcare ,
Healthcare Reform ,
Information Sharing ,
New Legislation ,
Reproductive Healthcare Issues ,
SCOTUS ,
State Privacy Laws
On October 30, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) released a...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
The increasing sophistication of generative artificial intelligence (AI) has had widespread effects on fields ranging from art and film to law and healthcare. The implications for copyright law principles, such as authorship,...more
9/15/2023
/ Algorithms ,
Artificial Intelligence ,
Authorship ,
Comment Period ,
Copyright ,
Copyright Infringement ,
Copyright Office ,
Fair Use ,
Intellectual Property Protection ,
Machine Learning ,
Public Comment ,
USPTO
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
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
The US Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a final rule to implement its authority under the 21st Century Cures Act to investigate allegations of information blocking and...more
8/3/2023
/ 21st Century Cures Act ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Final Rules ,
Health Care Providers ,
Health Information Technologies ,
Information Blocking Rules ,
Information Sharing ,
OIG ,
Physicians ,
Risk Mitigation ,
Webinars
On July 3, 2023, the US Department of Health and Human Services Office of Inspector General (OIG) published its long-awaited final rule implementing the 21st Century Cures Act provisions authorizing OIG to investigate claims...more
7/10/2023
/ 21st Century Cures Act ,
Amended Rules ,
Civil Monetary Penalty ,
CMP Law ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Enforcement Actions ,
Health Care Providers ,
Health Information Technologies ,
Information Blocking Rules ,
Information Technology ,
Investigations ,
OIG ,
Proposed Rules ,
Reporting Requirements
Healthcare is rapidly changing, with artificial intelligence (AI) and algorithmic models leading the transformation. In recent years, big data and machine learning algorithms have revolutionized our ability to predict...more
The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published a notice of proposed rulemaking on April 18, 2023, titled “Health Data, Technology, and...more
In a recent joint statement, several federal agencies warned that they will commit to enforcing their separate regulations against developers, deployers and users of AI systems, specifically citing civil rights, fair...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 January 17, 2023, the California Health and Human Services Agency (CalHHS) released updated drafts of four policies and procedures (P&Ps) under the California Data Exchange Framework (DxF) to support the implementation of...more
1/30/2023
/ California ,
Comment Period ,
Compliance ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Information Blocking Rules ,
ONC ,
Policies and Procedures ,
Policy Updates
By January 31, 2023, general acute care hospitals, clinical labs and certain physician organizations and medical groups in California are required to enter into the Single Data Sharing Agreement (DSA) to participate in the...more
12/22/2022
/ Acute Facilities ,
California ,
Clinical Laboratories ,
Data Privacy ,
Data Security ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Health and Safety ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Hospitals ,
Personally Identifiable Information ,
Physicians ,
Policies and Procedures ,
Social Services