Healthcare Info Blocking & Interoperability Legal Guide

Information Blocking and Interoperability in Healthcare

Rules and Resources

Interoperability and information blocking are critical issues impacting patient care, operational efficiency, technology decisions, and data privacy and cybersecurity. Healthcare providers, technology vendors, payors, and other stakeholders face growing challenges to meet regulatory requirements, exchange health data securely, and ensure that patient information flows seamlessly between systems. At the same time, they must navigate complex legal and compliance landscapes shaped by laws like the 21st Century Cures Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and federal and state antitrust laws.

With civil litigation based on state law claims of prohibited information blocking on the rise and government investigations and enforcement related to information blocking on the horizon, it is crucial for stakeholders to stay ahead of these issues and be prepared to defend data sharing decisions. Our team of healthcare regulatory lawyers, policy specialists, and litigators has unparalleled experience developing risk-based data sharing practices and representing clients in connection with Office of Inspector General (OIG) and other government investigations and defending litigation in the health IT context. Check back regularly for the latest legal and policy developments that may impact your organization.

Frequently Asked Questions (FAQs)

What is information blocking in healthcare?

Information blocking in healthcare under US federal law refers to practices that interfere with the access, exchange, or use of electronic health information (EHI), except as required by law or specified in an information blocking exception and:

  • If conducted by a certified health IT developer, health information network or health information exchange, such developer, network or exchange knows, or should know, that such practice is likely to interfere with access, exchange, or use of EHI; or
  • If conducted by a health care provider, such provider knows that such practice is unreasonable and is likely to interfere with access, exchange, or use of EHI.

Information blocking may include an act that prevents or discourages the sharing of patient data. The regulations apply to various actors, including healthcare providers, certified health IT developers, and health information networks and health information exchanges (HINs/HIEs).

Healthcare interoperability regulations are aimed at facilitating and encouraging information sharing among healthcare stakeholders and ensuring secure exchange of electronic health information (EHI) between different systems. Key requirements relate to patient access to EHI, exchange of EHI between providers and payors, payor-to-payor data exchange, application programming interfaces (API) implementation, data security, and quality data reporting, among other issues.

Healthcare interoperability requirements impact a wide range of industry stakeholders involved in the creation, exchange, and use of health information and data. Stakeholders include patients, healthcare providers, payors, researchers, health IT developers, revenue cycle management companies, and other service providers.

Failing to comply with the requirements can lead to financial penalties, loss of federal certification, and potential harm to patient care. The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) can investigate claims of information blocking and impose civil monetary penalties of up to $1 million (as adjusted for inflation) per information blocking violation against certified health IT developers, health information networks and health information exchanges. Penalties called “appropriate disincentives” are also authorized for information blocking violations by healthcare providers that participate in certain Medicare programs.

The Promoting Interoperability (PI) Program, formerly known as Meaningful Use, is a Centers for Medicare & Medicaid Services (CMS) program designed to encourage eligible professionals (EPs), eligible hospitals, and Critical Access Hospitals (CAHs) to adopt and meaningfully use certified Electronic Health Record (EHR) technology. It aims to improve patient care by facilitating the electronic exchange of health information and promoting data sharing.

The PI measures and requirements are typically updated each year through the relevant payment rule – the Inpatient Prospective Payment System (IPPS) rule for hospitals and CAHs and the Physician Fee Schedule, Merit-Based Incentive Program (MIPS) for EPs.

Information Blocking

Insights

Events

Health Lit Forum 2024

Event
October 2024

Information Blocking: Defense of Cures Act Investigations and Enforcement

Webinar
June 2024

How Not to Lose $1M: Preparing for HHS-OIG Info Blocking Enforcement

Webinar
August 2023

Trailblazing with Digital Health Pioneers: Episode 2

Video
May 2021

APIs and Information Blocking: What Providers Need to Know

Webinar
October 2020

New Rules from CMS and ONC – Interoperability and Information Blocking

Webinar
March 2020

TEFCA, Health Information Exchange, and Interoperability

Insights

Events

Regulatory Roadblocks and Opportunities: How to Thrive in a Shifting Healthcare Landscape

Event
June 2023

Around the Corner: Preparing Your Data for a Post COVID-19 World

Webinar
July 2020

New Rules from CMS and ONC – Interoperability and Information Blocking

Webinar
March 2020

MIPS, Promoting Interoperability, and Other Payment Rules

Insights