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Daniel Orenstein, JD

Senior Vice President, General Counsel, and Secretary

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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2021 Healthcare Trends: What Leaders Need to Know from COVID-19 to New Administration Policies

While much of the healthcare industry was eager to put 2020 behind it, the new year brings its own challenges, concerns, and promises. Trends in the three main categories of new Biden administration policy, care delivery, and healthcare technology will shape 2021, with key issues including the long-term effects of COVID-19, future emergency preparedness, and the outlook for the Affordable Care Act (ACA). Healthcare leaders can prepare for this pivotal year by understanding critical areas to watch within these categories and how events, activities, and political appointments will affect the healthcare ecosystem.

2021 Healthcare Trends: What Leaders Need to Know from COVID-19 to New Administration Policies (White Paper)

While much of the healthcare industry was eager to put 2020 behind it, the new year brings its own challenges, concerns, and promises. Trends in the three main categories of new Biden administration policy, care delivery, and healthcare technology will shape 2021, with key issues including the long-term effects of COVID-19, future emergency preparedness, and the outlook for the Affordable Care Act (ACA). Healthcare leaders can prepare for this pivotal year by understanding critical areas to watch within these categories and how events, activities, and political appointments will affect the healthcare ecosystem.

What Health Systems Need to Know About COVID-19 Relief Funding

During the emergency phase of the COVID-19 pandemic, almost half of all U.S. healthcare consumers postponed routine and non-emergent care, leaving organization with significant revenue loss across all care settings. In response to the widespread financial strain on the healthcare industry, Congress has allocated $100 billion in relief funding for hospitals and other healthcare providers. But while providers clearly need the financial relief, using it (including navigating terms and conditions and eligibility) has been less straightforward. Better understanding of these relief programs and compliance requirements will help organizations confidently optimize this assistance.

What Health Systems Need to Know About COVID-19 Relief Funding

During the emergency phase of the COVID-19 pandemic, almost half of all U.S. healthcare consumers postponed routine and non-emergent care, leaving organization with significant revenue loss across all care settings.
In response to the widespread financial strain on the healthcare industry, Congress has allocated $100 billion in relief funding for hospitals and other healthcare providers.
But while providers clearly need the financial relief, using it (including navigating terms and conditions and eligibility) has been less straightforward. Better understanding of these relief programs and compliance requirements will help organizations confidently optimize this assistance.

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:

1. Preventing Harm.
2. Promoting the Privacy of EHI.
3. Promoting the Security of EHI.
4. Recovering Costs Reasonably Incurred.
5. Responding to Request that are Infeasible.
6. Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms.
7. 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.

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.

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.