Starting in 2022, the Centers for Medicare & Medicaid Services (“CMS”) will require hospitals to measure themselves against the Office of the National Coordinator for Health IT’s (“ONC”) Safety Assurance Factors for EHR Resilience (“SAFER”) guides. CMS is implementing this requirement through its programmatic authority.[1] This is legally significant because it may create a discoverable … Continue reading Will this make healthcare technology SAFER?
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Is it Information Blocking? The Civil Discovery Edition
Several weeks ago a law firm filed an information blocking complaint on behalf an individual alleging that a hospital, its electronic health records vendor, and a “records staffing firm,” had engaged in information blocking for refusing to produce EHR records in a text-based PDF format.[1] The context is important: the requestor is a former patient … Continue reading Is it Information Blocking? The Civil Discovery Edition
21st Century Cures Part 3: Who’s a Health IT Developer?
21st Century Cures prohibition against information blocking applies to certain actors: healthcare providers, health information networks and health information exchanges, and health IT developers. In this post we’ll take a look at what it means to be a health IT developer and become subjection to the prohibition. A health IT developer is any developer who … Continue reading 21st Century Cures Part 3: Who’s a Health IT Developer?
21st Century Cures Part 2: Electronic Health Information
As noted in the first part of this series, 21st Century Cures prohibits any practice that could materially interfere with a patient’s (or their authorized representative’s) ability to access, exchange, or use their electronic health information without special effort – unless an exception applies. So just what is “electronic health information,” or “EHI”? This blog … Continue reading 21st Century Cures Part 2: Electronic Health Information
21st Century Cures: Part 1
In my first article on 21st Century Cures rulemaking, of what is to be many posts and presentations, we are first going to talk about the need to take this rule seriously, and its inevitable enforcement. 21st Century Cures prohibits “information blocking,” which is any practice that could materially interfere with a patient’s (or their … Continue reading 21st Century Cures: Part 1
Federal Health IT Strategic Plan (2020-2025) Part 2: Healthcare Providers, Value-based Programs, & Technology
In a prior post, I discussed what the Federal Health IT Strategic Plan meant for health IT developers. In short: a focus on interoperability and the enforcement of 21st Century Cures’ prohibition of information blocking. In this post I will look at what this proposed plan means to healthcare providers. First, the good news. The … Continue reading Federal Health IT Strategic Plan (2020-2025) Part 2: Healthcare Providers, Value-based Programs, & Technology
Practice Fusion Part 2: ONC Certification, the FCA, and What You Should Do NOW
My last post, “Practice Fusion Part 1: The AKS and What It Means for You,” looked at the Anti-Kickback Statute’s (“AKS”) role in Practice Fusion’s settlement with the Department of Justice (“DOJ”). The AKS is a criminal statute. If a prosecutor has enough evidence to charge, they can effectively hamstring a company through a criminal … Continue reading Practice Fusion Part 2: ONC Certification, the FCA, and What You Should Do NOW
Practice Fusion Part 1: The AKS and What It Means for You
This blog’s second post introduced a general legal and regulatory framework for certified EHRs, and the applicability of the antikickback statute to health IT vendors. It also referenced how the False Claims Act can create risk because of health IT’s relationship with physician reimbursement. On January 27, 2020, the Department of Justice (“DOJ”) executed a … Continue reading Practice Fusion Part 1: The AKS and What It Means for You
Federal Health IT Strategic Plan (2020-2025) Part 1: Health IT Developers, Information Blocking, & Interoperability
On January 15, 2020 the ONC published the 2020-2025 Federal Health IT Strategic Plan. This is the first post of a two-part series that will cover the plan from the perspective of (1) health IT developers, and (2) healthcare provider organizations. These strategic plans fit a couple of use cases for the federal government. They … Continue reading Federal Health IT Strategic Plan (2020-2025) Part 1: Health IT Developers, Information Blocking, & Interoperability
The Regulatory & Enforcement Framework for Health Information Technology
This post serves as a “set up” for this blog and all the subject matter we intend to cover. The blog is focused on “ehealth law.” That brings up the question of “what is ehealth law?” It’s not a scientific term; I use it to represent the statutory and regulatory framework that governs health information … Continue reading The Regulatory & Enforcement Framework for Health Information Technology
eHealth Law Blog 