ONC

News & Analysis as of

Healthcare Records Held Hostage: When ransomware attacks

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New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

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

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

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

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

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

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

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

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

New Guidance Maps HIPAA Security Rule to NIST Cybersecurity Framework to Help Providers Manage Cybersecurity Risk

In a world of looming data breaches and significant penalties for the release of protected health information, the complexities of cybersecurity and compliance with the HIPAA Security Rule can be incredibly daunting. In 2014,...more

Phase 2 of HIPAA Compliance Audits Now Underway

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

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

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

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

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

“Interoperable” Healthcare Data Will Be a Tempting Target

At a panel during last week’s Consumer Electronics Show in Las Vegas, Edith Ramirez, chair of the Federal Trade Commission – America’s top privacy regulator – said she would not wear a Fitbit personal fitness tracker. “I...more

ONC Releases Final 2016 Interoperability Standards Advisory

The Office of the National Coordinator for Health Information Technology (ONC) has released its final 2016 Interoperability Standards Advisory, which catalogs the “best available” interoperability standards and implementation...more

ONC Corrects EHR Certification Criteria Final Rule

The HHS Office of the National Coordinator for Health Information Technology (ONC) has published a notice correcting errors and clarifying provisions of its October 16, 2015 rule that finalized the 2015 edition health...more

Meaningful Use Stage 3 Final Rules Encourage Providers to Engage Patients in their Health Care

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

Meaningful Use Stage 3 Final Rule Reduces Provider Burdens

CMS and the Office of the National Coordinator for Health Information (ONC) recently released the 752-page final rule for Meaningful Use Stages 2 (MU2) and 3 (MU3). The final rule provides a flexible timeline for providers...more

CMS Adopts Changes to Medicare & Medicaid EHR Policies

The Centers for Medicare & Medicaid Services (CMS) has published a sweeping final rule with comment period that specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals...more

ONC Issues Final Health IT Interoperability Roadmap

The HHS Office of the National Coordinator for Health Information Technology (ONC) has released its final “Roadmap” to promote the secure exchange and use of electronic health information. The document, “Connecting Health and...more

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