News & Analysis as of

ONC

Office of the National Coordinator Issues Guidance After NotPetya Attack

Following the most recent ransomware attack, known as NotPetya, (among other nicknames), many health care entities were victims of the ransomware, which prompted the Office of the National Coordinator (ONC) to issue guidance...more

The Office of the National Coordinator Releases Guidance on Recent International Ransomware Campaign

by Foley & Lardner LLP on

With the news of the newest international ransomware campaign that is currently affecting some organizations within the Health Care sector, it is important to not only educate staff on necessary precautions, but also be aware...more

ONC and OCR Issue Joint Fact Sheet on Use of PHI for Public Health Activities

Whenever fact sheets or other guidance is issued by either the Office of the National Coordinator for Health Information Technology (ONC) or the Office for Civil Rights (OCR), it helps gain insight into the thinking of the...more

The U.S. Department of Health and Human Services Publishes Two Free Resources to Help Practices Navigate Healthcare IT

by Sherman & Howard L.L.C. on

The U.S. Department of Health and Human Services (“HHS”), Office of the National Coordinator (“ONC”) has published two free online playbooks to assist healthcare providers navigate healthcare information technology (“IT”)....more

ONC Revises Health IT Certification Program Requirements

by Reed Smith on

The HHS Office of the National Coordinator for Health Information Technology (ONC) has adopted a final rule to enable the ONC to directly review certified health information technology (IT) to determine whether it conforms to...more

A Stick to Balance the Carrot: ONC Finalizes a New Framework to Address Non-Conformities in Certified Health Information...

The Office of the National Coordinator for Health Information Technology (ONC) has released a final rule (Final Rule) introducing a new regulatory framework for certified health information technology (Health IT). The use of...more

ONC Contracting Guide Aims to Restore Balanced Bargaining Between Providers and EHR Vendors

by BakerHostetler on

The HHS Office of the National Coordinator for Health Information Technology (ONC) recently published a contracting Guide to assist healthcare providers when entering into electronic health record (EHR) contracts with EHR...more

ONC Releases Enhanced Regulatory Requirements to Improve Transparency for Health Information Technology Products

by Foley & Lardner LLP on

The Office of the National Coordinator for Health Information Technology (“ONC”) has operationalized regulatory requirements to improve transparency in health information technology (“health IT”). The regulations, which were...more

Healthcare Records Held Hostage: When ransomware attacks

by McAfee & Taft on

Imagine for a moment that your hospital or physician practice suddenly cannot access its electronic medical records. There hasn’t been a natural disaster. No, instead you are inexplicably staring at a computer screen from an...more

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

by Morgan Lewis on

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more

Joint Commission Ends Ban on the Texting of Physician Orders

In the Joint Commission Perspectives May 2016 edition, the Commission reversed its 2011 position prohibiting clinician texting of patient orders within accredited health care institutions, stating technological advancements...more

Wave of the Future: Government Releases New Tool to Aid Medical App Developers Comply with HIPAA

by Arnall Golden Gregory LLP on

This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more

FTC Releases "Cheat Sheet" for Developing a Secure Mobile Health Application

by Ballard Spahr LLP on

The Federal Trade Commission (FTC), in partnership with other federal agencies, has released an online tool that provides developers legal guidance for the creation of mobile health applications (apps). Companies that are...more

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

by Reed Smith on

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

by Foley & Lardner LLP on

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more

Health IT Regulators Seek Feedback on the Interoperability of Certified EHR Technology

by King & Spalding on

On April 8, 2016, the HHS Office of the National Coordinator for Health Information Technology (ONC) published a request for information (RFI) in the Federal Register (available here), seeking feedback on how to measure the...more

OIG Identifies Top 25 Unimplemented Recommendations for HHS Cost Savings/Quality Improvements

by Reed Smith on

The OIG has released the 2016 edition of its “Compendium of Unimplemented Recommendations,” which identifies what the OIG considers to be its top 25 unimplemented recommendations in terms of HHS program savings and/or quality...more

ONC Seeks Input on MACRA EHR Interoperability Requirements

by Reed Smith on

The Office of the National Coordinator for Health Information Technology (ONC) is seeking comments on how to achieve widespread exchange of health information through interoperable certified electronic health record (EHR)...more

FTC, ONC, OCR and FDA release online tool for mobile health app developers

While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more

Phase 2 of HIPAA Compliance Audits Now Underway

by Foley & Lardner LLP on

The Office of Civil Rights (OCR) within the U.S. Department of Health and Human Services (DHHS) recently announced that it has initiated Phase 2 of its audit program to assess Covered Entities’ and Business Associate’s...more

ONC Proposes Changes to Health IT Certification Program

by Reed Smith on

The HHS Office of the National Coordinator for Health Information Technology (ONC) has proposed changes to the ONC Health IT Certification Program that are intended to “further enhance the safety, reliability, transparency,...more

Data Privacy And Security Discussed In ONC HIT Congressional Report

by King & Spalding on

On February 29, 2016, the Office of the National Coordinator for Health IT (“ONC”) issued its annual report to Congress outlining the progress that has been made in electronic health information. The report focused heavily...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

Provider Confusion and Interoperability Concerns Prompt OCR and ONC to Release Guidance on PHI Sharing

Last Friday, the U.S. Department of Health and Human Services Office of the National Coordinator for Health IT (“ONC”) and the Office for Civil Rights (“OCR”) released two fact sheets regarding permitted uses and disclosures...more

The President’s Precision Medicine Initiative – The First Annual Check-Up

by Foley & Lardner LLP on

Watching President Obama’s recent 2016 State of the Union Address reminded me that one year has passed since the President announced a new “precision” or personalized medicine initiative to advance personalized, effective...more

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