Interoperability

The Office of the National Coordinator for Health Information Technology (“ONC”) finalized an interoperability rule (“Interoperability Rule”) under its authority in the 21st Century Cures Act. 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.

Once fully implemented, compliance with the Interoperability Rule will be necessary for applicable health care businesses. The consequences for noncompliance can be significant.

Epstein Becker Green’s Privacy, Cybersecurity, and Data Asset Management practice has been following the development of the Interoperability Rule closely to guide our health care clients to full compliance as each new requirement goes into effect.

Our Services

EBG is equipped to assist clients in meeting compliance obligations. Our services include the following:

  • 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 EHI

Publications

August 23, 2020 - Article
ONC’s New Information Blocking Prohibition Affects Health Care Providers, Health IT Developers, Health Information Exchanges, and Health Information Networks
Health Law Advisor Blog
Patricia Wagner, Ebunola Aniyikaiye

September 13, 2019 - Article
The FDA Looks Inward as It Tackles Interoperability
Health Law Advisor Blog
Ebunola Aniyikaiye

February 21, 2019 – Article
CMS and ONC Tag Team to Promote Sharing of Patient Data
Health Law Advisor Blog
Alaap Shah, Ebunola Aniyikaiye

August 28, 2018 – Article
Is there room for Blockchain in Health Care?
Health Law Advisor Blog
Ebunola Aniyikaiye

May 16, 2018 – Article
NIST Seeks Comments on Cybersecurity Standards for Patient Imaging Devices
Health Law Advisor Blog
Stuart Gerson

January 11, 2018 – Article
ONC’s Draft Interoperability Framework Lays Out Guidelines Pushing for More Cohesion Among Health Integrated Networks
Health Law Advisor Blog
Daniel Kim, Patricia Wagner

December 12, 2017 - Article
Information Blocking in the 21st Century Cures Act
Health Law Advisor Blog
Patricia Wagner

May 17, 2016 – Article
FDA Issues Draft Guidance Encouraging More Widespread Use of Electronic Health Record Data in Clinical Trials
Health Law Advisor Blog
Amy Dow

Webinars

Complimentary Webinar from EBG to Highlight Health Information Exchange Opportunities That Support Population Health Management Strategies
When: January 5, 2015 at 12:00pm
People: Patricia Wagner

How Will “Big Data” and “IT Integration” Impact Population Health Management Strategies?
When: June 14, 2014 at 12:00pm
People: Mark Lutes

Media Mentions

March 13, 2020 – In the News
Karen Mandelbaum Quoted in “Interoperability Rule Exposes Gaps in Protecting Privacy”
Modern Healthcare

July 11, 2019 – In the News
E. John Steren, Patricia Wagner quoted in FTC Submits Comments on Proposed “Information Blocking” Rule in Effort to Protect Market Competition

March 30, 2018 – In the News
Bradley Merrill Thompson Quoted in “Why the FDA’s Recent Glucose Monitoring System Approval Matters for Interoperability”
Becker’s Hospital Review

March 28, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Approves Interoperable Continuous Glucose Monitoring System”
Politico

September 5, 2017 – In the News
Bradley Merrill Thompson Quoted in “Government Urged to Avoid Burdening Health-Data Exchange Users”
Bloomberg Law

March 16, 2017 – In the News
Bradley Merrill Thompson Quoted in “Industry Wants HHS Scrutiny of Health Information Technology Office”
Bloomberg Law

March 3, 2016 – In the News
Bradley Merrill Thompson Quoted in “Hypertense About Blood Pressure App”
Politico

February 28, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Device Interoperability Guide Offers Clarity, But Lacks Incentives”
Politico

February 22, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Seeks Feedback on Plan for Medical Device Interoperability”
Health Data Management

January 26, 2016 – In the News
Bradley Merrill Thompson Discusses FDA’s Draft Guidance on Medical Device Interoperability with Multiple Publications

June 4, 2015 – In the News
Bradley Merrill Thompson Quoted in “Burgess Is Reworking His Interoperability Bill – Privacy Advocates Speak Out – Docs Attack 21st Century Bill”
Politico

January 9, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Puts Interoperability Guidance on Back Burner”
Modern Healthcare

December 12, 2014 – In the News
Bradley Merrill Thompson Provides Commentary in “ONC Outlines Plan to Expand Telehealth, Mobile Health”

June 3, 2014 – In the News
Bradley Merrill Thompson Quoted in “Lawmakers Question ONC Authority To Take on New Health IT Activities”

May 30, 2014 – In the News
Bradley Merrill Thompson Quoted in “ONC Announces Realignment”

April 11, 2014 – In the News
Bradley Merrill Thompson Quoted in “EU Appears Open to Suggestions on Mobile Health Oversight”

December 16, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Digital Health Regulation Debate Continues at mHealth Summit”

March 7, 2013 – In the News
At HIMSS, Interoperability Calls Shotgun, in Medical Device and Diagnostic Industry

October 1, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Federal Task Force Recommends Stepped up Role for FCC in mHealth Policy”