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Daniel Orenstein, JD

Prior to joining Health Catalyst Dan Orenstein was at athenahealth, Inc. (NASDAQ: ATHN) for 10 years, the last 7 as General Counsel and Secretary. Prior to that, Dan practiced in the areas of corporate, intellectual property, and healthcare law with law firms in Boston and Washington, D.C. He has written and presented on health care law and IT topics throughout his career. He also served as a leader of the American Health Lawyers Association’s Health IT practice group.

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Daniel Orenstein, JD

Exceptions to Information Blocking Defined in Proposed Rule: Here’s What You Need to Know

Information blocking practices inhibit care coordination, interoperability, and healthcare’s forward progress.  The ONC’s proposed rule ushers in the next phase of the Cures Act by defining information blocking practices and allowed exceptions. To make the final rule as strong as possible, exceptions should be narrowly defined. In proposed form these include the following:

Preventing Harm.
Promoting the Privacy of EHI.
Promoting the Security of EHI.
Recovering Costs Reasonably Incurred.
Responding to Request that are Infeasible.
Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms.
Maintaining and Improving Health IT Performance.

This article covers each of these exceptions and discusses what to watch for in the final version of the rule.

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Daniel Orenstein, JD

EHR Integration: Achieving this Digital Health Imperative

As the digital trajectory of healthcare rises, health systems have an array of new resources available to make more effective and timely care decisions. However, to use these data analytics, machine learning, predictive analytics, and wellness applications to gain real-time, data-driven insight at the point of care, health systems must fully integrate the tools with their EHRs. Integration brings technical and administrative challenges, requiring organizations to coordinate around standards, administrative processes, regulatory principles, and functional integration, as well as develop compelling integration use cases that drive demand. When realized, full EHR integration will allow clinicians to leverage data from across the continuum of care (from health plan to patient-generated data) to improve patient diagnosis and treatment.

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Daniel Orenstein, JD
Carolyn Wong Simpkins, MD, PhD

The Impact of FDA Digital Health Guidance on CDS, Medical Software, and Machine Learning

The FDA recently released guidance documents on the use of clinical decision support (CDS) and medical software that may be of concern to forward-thinking healthcare innovators who rely on these technologies to deliver exceptional care and improve outcomes. What will be the impact of this guidance on machine learning and predictive analytics efforts? How will the guidance affect timelines, costs, and effectiveness of ongoing machine learning implementation?
As healthcare delivery increasingly relies on digital innovation and support, more questions emerge about the governance of the accompanying tools and technology.
This article provides a summary of the FDA guidance on CDS, how CDS is defined, whether or not CDS is exempt from regulation, and how the FDA intends to enforce compliance. It also summarizes the FDA guidance on medical software, what software is exempt from regulation, and helps to answer some of the questions surrounding the digital health space.

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Daniel Orenstein, JD

Healthcare Reform: Is Bipartisan Legislation Possible?

The effort to repeal and replace the ACA in 2017 failed, leaving the industry wondering if bipartisan healthcare reform is possible in today’s political climate. This article explains why it is possible, by taking a close look at why repeal and replace failed, and why the 21st Century Cures Act and MACRA have been successful.
To stand a chance of being successful, proposed bipartisan healthcare legislation will most likely have one (or more) of five features:

Driven by practical need rather than politics.
Focuses on cost control/cost reduction.
Targets areas that are expected to save money.
Doesn’t involve creating new programs.
Stabilizes the ACA.

There are many bipartisan healthcare legislation opportunities, from expanding the use of HSAs to innovation waivers; opportunities that won’t come to fruition unless the proposed legislation tackles practical problems.

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Carolyn Wong Simpkins, MD, PhD
Daniel Orenstein, JD

Machine Learning in Healthcare: How it Supports Clinician Decisions—and Why Clinicians are Still in Charge

Machine learning in healthcare is transforming healthcare with its ability to tackle data variability and complexity. Everyone in healthcare should embrace this new technology and its ability to deliver more precise, faster, data-driven insight to clinical teams.
But just as machine learning has benefits, it also has limitations; for example, it loses its impact when implemented without realistic expectations or without thorough integration with existing clinical processes.
As the FDA works to publish guidance on digital health services, including governance regarding the use of algorithms to support clinical decisions, it’s important for everyone in the industry to hold themselves accountable for the quality of the data and the processes that put this data in front of clinicians.
Machine learning is transforming the way health systems deliver care to patients by surfacing insights to clinicians at the point of care; but, ultimately, the clinician considers the entire clinical picture to determine the most appropriate plan for patients.

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Daniel Orenstein, JD

Interoperability in Healthcare Delivers Critical Health Information at the Point of Care

Interoperability in healthcare, despite frequent objections by EHR vendors and health systems (e.g. “EHR integration is too difficult to manage”), is integral to delivering high quality patient care.
Interoperability means different things to different health system stakeholders, from leaders seeing it as a purchase they must defend, to clinicians relying on it to get the information they need, when they need it. But it boils down to delivering the highest-quality, most effective, and most efficient care to patients—a goal that’s easier to define than achieve.
One of interoperability’s most important use cases, EHR integration, is challenged by EHR vendors and health systems worried about integration challenges, from HIT vendors wanting to integrate too many tools, to EHR access fears. Fortunately, objections are dissipating with the introduction of national interoperability policy and better cooperation among industry participants.
Amidst these distractions, health systems need to regain focus on interoperability’s top goal: improving patient care by making the best information available at the point of care.

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Daniel Orenstein, JD

Three Affordable Care Act Questions Everyone in Healthcare Is Asking

Trump/Republican rhetoric recently met reality when it comes to the Affordable Care Act (ACA). The latest version of the bill that passed in the House is far from a complete repeal and replacement of the ACA. However, the bill includes significant changes to healthcare policy and coverage, from severe Medicaid cuts to shifting financial accountability.
ACA uncertainty has healthcare leaders concerned about how to plot a path forward, with three questions on the top of their minds:

What will the final bill look like?
How do I plan for the changes?
What should happen next to fix the problems with the ACA?

Answers to these questions, although helpful, distract the industry from the ultimate goal: delivering on healthcare’s longstanding mission to provide quality, affordable healthcare. In short, health systems need to continue prioritizing patients until the ACA dust settles in Washington.

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Daniel Orenstein, JD

Is Value-Based Healthcare Here to Stay? Looking for Answers in New Policies

Healthcare leaders are eager for a modicum of clarity when it comes to the industry’s shift to value-based healthcare given the uncertainties of Congress and the new Administration.
Fortunately, an analysis of three key pieces of information tells us value-based healthcare is likely here to stay:

The 21st Century Cures Act (Cures).
The Executive Order on reducing the “burden” of the Affordable Care Act (ACA).
Tom Price’s comments at his confirmation hearings.

It is a relatively safe bet that value-based healthcare delivery and payment programs will continue to be supported by federal law and regulation for several reasons:

Bipartisan support: The success of Cures indicates that bipartisan cooperation will continue on key healthcare issues.
Market-based innovation: The emerging evidence is that Congress and the Administration will support innovation in payment and delivery models.
Support for Existing ACA Innovation programs: Although highly uncertain, there are some indications that not all of the ACA will be scrapped.

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Daniel Orenstein, JD

Why the 21st Century Cures Act Is Great News for Healthcare

The 21st Century Cures Act, approved by the U.S. Senate on December 7, 2016, is perhaps the most significant federal legislation as it relates to health information technology (HIT) in years. What the Cures Act means for HIT companies and providers is two key things:

Health information interoperability will be strongly promoted (involves the development of a “trusted exchange framework” which is expected to facilitate the exchange of health information nationally and locally).
Information blocking practices will be strongly prohibited (e.g., Implementing HIT in nonstandard ways likely to increase the complexity or burden of accessing, exchanging, or using electronic health information—with fines as much as $1,000,000).

The Act’s impact on the healthcare industry is monumental, with significantly improved provider access to clinical, financial, and operational data to improve outcomes. The Act’s provisions to promote the free exchange of health information will improve care coordination industrywide.

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