Overview
Under its authority in the 21st Century Cures Act, the Office of the National Coordinator for Health Information Technology (or “ONC”) finalized an interoperability rule (“Interoperability Rule”). The Interoperability Rule is intended to enable patients to seamlessly and securely access and use their health information stored in electronic health records through third-party applications.
Compliance with the Interoperability Rule, once it is fully implemented, will be necessary for applicable health care businesses. The consequences of noncompliance can be significant.
Epstein Becker Green’s Privacy, Cybersecurity, and Data Asset Management practice has been closely following the development of the Interoperability Rule to guide our health care clients to full compliance as each new requirement goes into effect.
Comprehensive Services
Epstein Becker Green is equipped to assist clients in meeting their compliance obligations. Our full range of services includes:
- Assisting clients with designing and building compliance programs to guard against information blocking
- Analyzing and revising existing HIPAA policies and procedures (and developing new ones, where needed) to allow for coordination with the organization’s information blocking compliance program
- Assisting clients with establishing a process and developing criteria for vetting app developers
- Updating and renegotiating services agreements and business associate agreements to reflect the requirements and responsibilities under the Interoperability Rule
- Defending clients in investigations of information blocking
- Defending clients against information blocking allegations
- Advising health IT developers on new conditions and maintenance of certification requirements, including real-world testing and biannual attestations required under the Interoperability Rule
- Assisting health IT developers with designing a methodology to address situations where exceptions apply and information blocking is an appropriate refusal to disclose electronic health information
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Focus Areas
Industries
Trending Issues
Experience
Contacts
- Senior Counsel
- General Counsel / Chief Privacy Officer
Media
Events
Past Events
- Spring 2024
- November 18, 2022
- October 28, 2021
Insights
Insights
- PublicationsThe Challenge of AI Governance: The Blessing and the Curse of Safeguarding Personal Data2 minute read
- Media CoverageDennis Sapien-Pangindian Quoted in “Info Blocking ‘Disincentives’ Rule Brings Penalties; Data-Sharing ...2 minute read
- Firm Announcements
Elizabeth Scarola Named to the 2024 Florida Rising Stars List
7 minute read - PublicationsAdvancing Interoperability and Improving Prior Authorization: No One Said It Would Be Easy!18 minute read
- PublicationsHHS Publishes Proposed “Disincentives Rule” to Prevent Information Blocking by Health Care Providers15 minute read
- Firm Announcements
Elizabeth Scarola Named to the 2023 Florida Rising Stars List
6 minute read - Media Coverage
Epstein Becker Green’s Diagnosing Health Care Podcast Featured in It’s All Hearsay! – “The End of the ...
2 minute read - Media CoverageElizabeth Scarola Featured in “People on the Move”1 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2023 PromotionsOctober 28, 20225 minute read
- Firm Announcements
Elizabeth Scarola Named to the 2022 Florida Rising Stars List
6 minute read - BlogsInteroperability and Its Impact on Payors6 minute read
- BlogsInformation Blocking – How Did I Become an “Actor”?5 minute read
- Media Coverage
Alaap Shah, Elizabeth Scarola Featured in AHLA’s Speaking of Health Law Podcast, “Opportunities and Risks with ...
2 minute read - PublicationsTop Ten Issues in Health Law 2021: Sharing Is Caring? Opportunities and Risks with Increased Interoperability in Health Care ...1 minute read
- PublicationsUSA: HIPAA and Wearable Technology – Does It Provide a Loophole?2 minute read
- PublicationsDesigning a Trusted Framework for the Application of AI in Health Care2 minute read
- BlogsONC’s New Information Blocking Prohibition Affects Health Care Providers, Health IT Developers, Health Information ...4 minute read
- Media CoverageKaren Mandelbaum Quoted in "Interoperability Rule Exposes Gaps in Protecting Privacy"2 minute read
- BlogsThe FDA Looks Inward as It Tackles Interoperability3 minute read
- PublicationsFTC Submits Comments on Proposed “Information Blocking” Rule in Effort to Protect Market Competition3 minute read
- BlogsCMS and ONC Tag Team to Promote Sharing of Patient Data4 minute read
- BlogsIs there room for Blockchain in Health Care?4 minute read
- BlogsNIST Seeks Comments on Cybersecurity Standards for Patient Imaging Devices3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Why the FDA's Recent Glucose Monitoring System Approval Matters for Interoperability" ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Approves Interoperable Continuous Glucose Monitoring System"2 minute read
- BlogsONC’s Draft Interoperability Framework Lays Out Guidelines Pushing for More Cohesion Among Health Integrated Networks ...4 minute read
- BlogsInformation Blocking in the 21st Century Cures Act2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Government Urged to Avoid Burdening Health-Data Exchange Users"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Wants HHS Scrutiny of Health Information Technology Office"2 minute read
- BlogsFDA Issues Draft Guidance Encouraging More Widespread Use of Electronic Health Record Data in Clinical Trials5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Hypertense About Blood Pressure App"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Feedback on Plan for Medical Device Interoperability"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Device Interoperability Guide Offers Clarity, But Lacks Incentives"1 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA's Draft Guidance on Medical Device Interoperability with Multiple Publications ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Burgess Is Reworking His Interoperability Bill - Privacy Advocates Speak Out - Docs ...1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Puts Interoperability Guidance on Back Burner”2 minute read
- Firm AnnouncementsComplimentary Webinar from EBG to Highlight Health Information Exchange Opportunities That Support Population Health ...6 minute read
- Media CoverageBradley Merrill Thompson Provides Commentary in "ONC Outlines Plan to Expand Telehealth, Mobile Health"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lawmakers Question ONC Authority To Take on New Health IT Activities"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "ONC Announces Realignment"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "EU Appears Open to Suggestions on Mobile Health Oversight"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Digital Health Regulation Debate Continues at mHealth Summit"2 minute read
- Media CoverageAt HIMSS, Interoperability Calls Shotgun, in Medical Device and Diagnostic Industry2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Federal Task Force Recommends Stepped up Role for FCC in mHealth Policy" ...2 minute read