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 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
On November 4, 2020, the US Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published an interim final rule with comment period in the Federal Register that...more
On April 21, 2020, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) announced that they will...more
On March 9, 2020, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released its long-awaited final rule identifying conduct that does not...more
The Office of the National Coordinator for Health Information Technology recently released a final rule under the 21st Century Cures Act to promote interoperability of health IT and advance access, exchange or use of...more
The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more
2/4/2020
/ 21st Century Cures Act ,
CEHRT ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Health Care Providers ,
Information Technology ,
Medical Research ,
Patient Privacy Rights ,
PHI ,
Strategic Planning ,
Technology ,
Value-Based Care
A recent update to the Office of Management and Budget (OMB) website suggests that the answer is “yes”—though that depends on how one defines “soon.” According to its website, OMB received the Office of the National...more
The ONC recently released a proposed rule under the 21st Century Cures Act to promote interoperability of health IT and advance access, exchange or use of electronic health information. If finalized, the proposed rule would...more
3/28/2019
/ 21st Century Cures Act ,
APIs ,
Conditional Certification ,
Cost Recovery ,
Data Blocking ,
Data Privacy ,
Data Protection ,
Data-Sharing ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Information Technologies ,
License Fees ,
ONC ,
Proposed Rules
The ONC finally released its long-awaited proposed rule to implement the “information blocking” prohibition of the 21st Century Cures Act by identifying conduct that is not information blocking. If finalized, ONC’s proposed...more
2/15/2019
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Data Privacy ,
Data Protection ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Exceptions ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
ONC ,
Patient Privacy Rights ,
Policies and Procedures ,
Proposed Rules ,
Public Comment ,
Regulatory Agenda ,
Regulatory Requirements
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
1/21/2017
/ 21st Century Cures Act ,
Ambulatory Surgery Centers ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Long Term Care Facilities ,
Manufacturers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
MedPAC ,
Mental Health ,
Mental Health Parity Rule ,
National Institute of Health (NIH) ,
Off-Campus Departments ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Research and Development ,
Small Business ,
Substance Abuse ,
Telehealth ,
Transparency