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 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 September 17, 2020, the Office of Management and Budget received an Interim Final Rule for review from the Office of the National Coordinator for Health IT (ONC) entitled “Information Blocking and the ONC Health IT...more
ONC finalized changes to the certification criteria for application programming interfaces (APIs) that have the potential to improve the ability of patients to access electronic health information through a third party...more
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
CMS issued a long-awaited proposed rule aimed at enhancing interoperability and increasing patient access to health information. If finalized, CMS’s proposed rule may require hospitals and payors to make significant...more
2/21/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Participation (CoP) ,
Data Collection ,
Data-Sharing ,
Electronic Medical Records ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
Medicaid ,
Medical Records ,
Medicare ,
Patient Access ,
Proposed Rules ,
Public Comment ,
Qualified Health Plans ,
Request For Information
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
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more
On October 16, 2015, the Centers for Medicare and Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) of the U.S. Department of Health and Human Services published the...more