Information blocking has been a hot-button issue for years as it has impeded innovation and patient healthcare options for too long. The 21st Century Cures Act (Cures Act) sought to eliminate these problems but information blocking persisted. However, in February 2019 the Office of the National Coordinator for Health Information Technology (ONC) announced a proposed rule with consequences to non-compliance with the Cures Act that may finally force true interoperability. As a healthcare decision maker you have a real opportunity to build an innovation strategy around these changes. To learn how, view this webinar. True data interoperability enables innovation and better patient experience. In aggregate, both of these activities have the potential to accelerate the shift away from fee-for-service and towards fee-for-value healthcare. Dan Orenstein has spent much of his career providing legal counsel to healthcare organizations on regulatory and risk management issues as well as how to implement growth initiatives that comply with healthcare laws and regulations. That experience has made him an expert in applying policy to healthcare strategy. He has studied the proposed rule and in this webinar he will provide a summary of the existing legislation, implications of non-compliance with the proposed rule as well as insight into putting it into practice. View this webinar and learn: - To identify information blocking practices - Seven exceptions to the information blocking provision and how they may apply to your work - Summary of the public comments about the proposed rule and the overall perception of it in the industry - The potential impact to your healthcare organization

1. What the ONC’s
Proposed Rule on
Information Blocking
Means for Your Work
June 18, 2019
Daniel Orenstein
General Counsel, Health Catalyst

2. • Introduction
• Interoperability
• 21st Century Cures Act & Proposed Rule
• Examples of Information Blocking Practices
• Proposed Exceptions to Information Blocking
Practices
• Notable Public Comment Themes
• How Healthcare Organizations May Be
Affected
Agenda

3. • Introduction
• Interoperability
• 21st Century Cures Act & Proposed Rule
• Examples of Information Blocking Practices
• Proposed Exceptions to Information Blocking
Practices
• Notable Public Comment Themes
• How Healthcare Organizations May Be
Affected
Agenda

4. © 2018
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Catalyst
Interoperability
“The ability of a system to exchange electronic
health information with and use electronic health
information from other systems without special
effort on the part of the user.”
The ONC has defined “Interoperability” as:
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Interoperability
Four fundamental features
4
Finding
Sending
Receiving
Text HereUsing/Integrating
Interoperability

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Interoperability
• Automated provision of clinical decision support (CDS)
outputs as part of the workflow resulted in a
significantly greater likelihood of a clinical intervention.1
• Similar findings for provision of CDS information at the
time and location of decision making.
• There is an association between availability of CDS and
improved quality of care.
• Significant benefit in making innovative tools, analyses,
and applications available from third party sources.
Growing evidence shows substantial treatment and efficiency gains
5 1
Kawamoto, et al, Information in Practice, Mar. 14, 2005.

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Interoperability
• Significant benefit in leveraging data from other
sources—clinical, patient-generated, or socially-based
determinants of care.
• CDS can help with results such as reduced sepsis
mortality, reduced hospital readmission rates, and
reduction in unnecessary testing and lab utilization.
Growing evidence shows substantial treatment and efficiency gains
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In addition to CDS, there are many information processing and analysis areas
that are not typically performed by an EHR which could be enhanced through
third-party systems:
• Precision medicine
• Population health analytics
• Integration of fitness device data
• Monitoring and improvement of medication adherence
• Chronic disease management
• Identification of high-risk and high cost patients
• Care coordination
Interoperability
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EHR systems have made great strides, but they have been limited in their ability
to integrate with third-party systems.
• “EHRs principally show a doctor information she entered previously, but not the
wide range of data and services that should drive cost-efficient care and decision
making.”1
• The structural paradigm for EHRs to date has been an electronic-based version of
the paper encounter documentation.
• Factors that are used in evaluating social determinants of care are typically not
included in the EHR.
• EHRs are provider-centric, and do not include patient-generated content.
Interoperability
8 1
Kenneth Mandl, Joshua C. Mandel, Isaac Kohane, Cell Syst. 2015.

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• HIEs have had some notable successes at the regional level, but have had
challenges finding a sustainable economic model.
• Government-conceived efforts haven’t taken solved the interoperability problem:
Blue Button, Direct, Trusted Exchange Framework.
• Private efforts, such as Commonwell and Carequality, have struggled to make a
broad impact.
• Lack of national patient identifier has slowed progress.
• Information blocking practices have slowed progress.
Interoperability Efforts Have Faced
Stiff Headwinds
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11. • Introduction
• Interoperability
• 21st Century Cures Act & Proposed Rule
• Examples of Information Blocking Practices
• Proposed Exceptions to Information Blocking
Practices
• Notable Public Comment Themes
• How Healthcare Organizations May Be
Affected
Agenda

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Catalyst
What type of organization do you work for?
1. Provider – 36%
2. Payer – 5%
3. HIE – 11%
4. Vendor – 26%
5. Consultant – 24%
Poll Question #1
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The 21st Century Cures Act
• The Cures Act is broad and sweeping legislation that
covers many topics, mostly on streamlining and
accelerating the discovery of new drugs and medical
devices. It includes provisions to improve mental health
and substance abuse treatment and to improve patient
access to new therapies, among many other areas
covered by the Act.
• The Cures Act also establishes programs and oversight
to promote health information interoperability and to
prohibit “information blocking” practices.
Became law on December 13, 2016 with broad bipartisan support
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The 21st Century Cures Act
“Interoperable” HIT is defined in the Act as HIT that:
• Enables the secure exchange of electronic information with,
and use of electronic health information from, other HIT
without special effort on the part of the user.
• Allows for complete access, exchange, and use of all
electronically accessible information for authorized use under
applicable State or Federal law.
• Does not constitute information blocking.
The National Coordinator is to develop a “trusted exchange
framework” to facilitate health information exchange.
• The framework is to include a “common agreement” and
establishment of a national provider contact directory.
Promotes the interoperability of health information technology (HIT)
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The 21st Century Cures Act
“Information blocking” is defined as any practice that, except as required by law or
specified by the Secretary of HHS, is likely to interfere with, prevent, or materially
discourage access, exchange, or use of electronic health information, and:
• If conducted by a HIT developer, exchange, or network, they know or should know that
such practice is likely to interfere with, prevent, or materially discourage the access,
exchange or use of electronic health information.
• If conducted by a provider, the provider knows that such practice is unreasonable and
likely to interfere with, prevent, or materially discourage access, exchange, or use of
electronic health information.
Prohibits “information blocking,” and provides for penalties up to $1M
per violation
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The 21st Century Cures Act
• Practices that restrict authorized access, exchange, or use under applicable State
or Federal law of information for treatment and other permitted purposes, including
transitions between health information technologies.
• Implementing HIT in nonstandard ways that are likely to substantially increase the
complexity or burden of accessing, exchanging or using EHI.
• Implementing HIT in ways likely to:
• Restrict access, exchange, or use of EHI with respect to exporting complete information
sets or in transitioning between HIT systems.
• Lead to fraud, waste, or abuse, or impede innovations and advancements in health
information access, exchange, and use, including in care delivery.
Information blocking practices that are prohibited
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The 21st Century Cures Act
• HHS is to identify “reasonable and necessary activities”
that do not constitute information blocking.
• No enforcement of actions earlier than 30 days after
enactment of the Cures Act.
Requiring establishment of regulatory exceptions
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The 21st Century Cures Act
Any information blocking complaint received by ONC which
might identify the source:
• Shall not be disclosed by ONC except as necessary to carry out
the information blocking provisions.
• Shall be exempt from FOIA disclosure.
• May be used by the FTC IG for reporting if the source is
protected.
Information blocking complaints to be protected from disclosure
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On March 4, 2019, HHS published the Proposed Rule implementing the Cures
Act provisions on interoperability, information blocking, and the use of APIs.
The Proposed Rule
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• 60 day comment period, extended to 90 days.
The Proposed Rule:
1. In the preamble, provides a detailed discussion of
examples of information blocking practices.
2. Provides for seven exceptions to the prohibition on
information blocking.
3. Requires the provision of APIs as condition for certification
for electronic health information technology.

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How much does information availability and exchange affect your
organization’s effectiveness?
1. No impact – 2%
2. Some impact – 14%
3. Moderate impact – 21%
4. High impact – 41%
5. Significantly impairs effectiveness – 21%
Poll Question #2
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21. • Introduction
• Interoperability
• 21st Century Cures Act & Proposed Rule
• Examples of Information Blocking
Practices
• Proposed Exceptions to Information Blocking
Practices
• Notable Public Comment Themes
• How Healthcare Organizations May Be
Affected
Agenda

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Examples of Information Blocking Practices
Five categories:
1. Restrictions on Access, Exchange, or Use
2. Limiting or Restricting the Interoperability of Health IT
3. Impeding Innovations and Advancements in Access,
Exchange, or Use of Health-IT-enabled Care Delivery
4. Rent-seeking and Other Opportunistic Pricing Practices
5. Non-standard Implementation Practices
Examples start on page 364 of the PDF version
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Examples of Information Blocking Practices
Examples:
• A health system requires staff to obtain patient written consent before sharing patient’s
EHI with unaffiliated providers, even though this is not required by HIPAA or state
law.
• An EHR vendor sues to prevent a clinical data registry from providing interfaces to
physicians who use the developer’s EHR to submit EHI to the registry, claiming that the
registry infringes the vendor’s copyrights in its database that incorporate data
mappings that reference table headings and rows of the EHR database in which EHI
is stored.
• A vendor that allows third party developers to use its platform requires that third party
developers to grant rights in their source code to the vendor.
Category 1 – Restrictions on Access, Exchange, or Use
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Examples of Information Blocking Practices
Examples:
• A hospital configures its EHR so that users cannot easily
send referrals and EHI to unaffiliated providers.
• An EHR vendor prevents (e.g., by imposing high fees)
third-party clinical decision support (CDS) app from writing
EHI to the EHR, when a provider has authorized it.
• Providers selectively disabling EHR functionality that allow
transmission of EHI to third parties, or take steps to
delay transmissions.
Category 2 – Limiting or Restricting the Interoperability of Health IT
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Examples of Information Blocking Practices
Examples:
• An EHR vendor requires third party applications to be reviewed
for security before use but delays the review or conducts it in a
discriminatory manner.
• EHR vendor will not provide technical documentation to a
systems integrator engaged by a provider unless the systems
integrator signs a broad non-compete that prohibits them from
working with other vendors.
• A health IT vendor discourages customer from getting data
integration capabilities from a third party claiming it will have
that functionality soon. In reality the capabilities it is developing
are more limited and 12-18 months from being in
production.
Category 3 – Impeding Innovations and Advancements in Access,
Exchange, or Use of Health-IT-enabled Care Delivery
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Examples of Information Blocking Practices
Examples:
• An analytics company’s services to provider customers
include de-identifying EHI and combing it with other data to
identify areas for quality improvement. The customer’s
EHR vendor demands a percentage of revenue from the
analytics company’s services in excess of its reasonable
costs in exchange for access to data in the EHR.
• An EHR vendor charges more to export or use EHI when a
provider is transitioning to competing technology or trying
to export data for use with an HIE.
Category 4 – Rent-seeking and Other Opportunistic Pricing Practices
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Examples of Information Blocking Practices
Examples:
• An EHR vendor implements the C-CDA for receiving
transition of care summaries but only sends them in a
proprietary or obsolete format.
• A health IT vendor uses the “required” portions of a
widely adopted industry standard but implements
proprietary standards wherever it has discretion, even
when standard formats are available.
Category 5 – Non-standard Implementation Practices
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28. • Introduction
• Interoperability
• 21st Century Cures Act & Proposed Rule
• Examples of Information Blocking Practices
• Proposed Exceptions to Information
Blocking Practices
• Notable Public Comment Themes
• How Healthcare Organizations May Be
Affected
Agenda

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Exceptions to Information Blocking Practices
Description:
An organization may engage in practices that are reasonable and
necessary to prevent physical harm to a patient or other person.
Conditions:
• Must have a reasonable basis to believe that its practice will directly
and substantially reduce the likelihood of harm to a patient.
• Must have adopted a policy that addresses patient harm or make case
by case findings that a disclosure of EHI could result in patient harm.
Comments:
This exception is broad, could be applied subjectively with wide
variation, and could be misused.
Exception 1: Preventing Harm
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Exceptions to Information Blocking Practices
Description:
An organization may engage in practices to protect the
privacy of EHI.
Conditions:
• Must demonstrate a basis for its actions in HIPAA or other
privacy laws.
• Must be tailored to the specific privacy risks addressed, and
implemented in a consistent and non-discriminatory manner.
Comments:
This exception is broad, could be applied subjectively with
wide variation, and could be misused.
Exception 2: Promoting the Privacy of EHI
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Exceptions to Information Blocking Practices
Description:
An organization may implement measures to protect the security of EHI.
Conditions:
• Must be tailored to the specific measures necessary to protect the security of EHI, and
implemented in a consistent and non-discriminatory manner.
• If the organization has a security policy, it must be consistent with a widely accepted
framework and meet other criteria.
• If the organization does not have a policy, it must make case by case determinations
on whether its practices are necessary to protect the security of EHI.
Comments:
This exception is broad, could be applied subjectively with wide variation, and could
be misused.
Exception 3: Promoting the Security of EHI
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Exceptions to Information Blocking Practices
Description:
An organization may charge for costs it reasonably incurs.
Conditions:
• Must use objective and verifiable criteria, uniformly applied.
• Must be reasonably related to vendor’s cost of access,
exchange, use of EHI.
• Must be allocated among all customers.
• May not be based on whether requestor is a competitor, or
sales, profit, revenue of requestor.
Comments:
Reasonable cost is hard to verify and can be very subjective.
Exception 4: Recovering Costs Reasonably Incurred
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Exceptions to Information Blocking Practices
Description:
An organization may decline to provide access, exchange, or use of
EHI if infeasible.
Conditions:
• Must use objective and verifiable criteria, uniformly applied.
• Must demonstrate substantial burden to making EHI available,
assessing multiple factors, including whether it provides comparable
access to others, whether other sources are available for the EHI.
• Must respond to all requests and provide denials in writing.
Comments:
The decision to deny access, including evaluation of the facts and
circumstances, is highly subjective.
Exception 5: Responding to Requests That Are Infeasible
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Exceptions to Information Blocking Practices
Description:
An organization (e.g., EHR vendor) can claim IP rights, but it must
license interoperability elements.
Conditions:
• Must respond to a request to license IP to enable access to EHI within 10 days.
• Must offer a license on reasonable and non-discriminatory terms.
• The license must have a broad scope including product development
and marketing, ability to offer interoperable products.
• No restrictions such as non-competes, requirement to license back IP, exclusivity.
Comments:
Wide latitude to organizations to decide if their interoperability elements include IP.
Exception 6: Licensing of Interoperability Elements
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Exceptions to Information Blocking Practices
Description:
An organization may make technology temporarily unavailable
to perform maintenance.
Conditions:
• Technology must be unavailable no longer than necessary to
perform the maintenance.
• Must be implemented in a consistent and non-discriminatory
manner.
Comments:
This exception reflects common sense and is unlikely to be
controversial.
Exception 7: Maintaining and Improving Health IT Performance
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36. • Introduction
• Interoperability
• 21st Century Cures Act & Proposed Rule
• Examples of Information Blocking Practices
• Proposed Exceptions to Information Blocking
Practices
• Notable Public Comment Themes
• How Healthcare Organizations May Be
Affected
Agenda

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Timing
• Need more time.
• Should be finalized ASAP.
Notable Public Comment Themes
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Definition of EHI
• Expand to include other/more information.
• Restrict to manageable standard (e.g., USCDI).
Notable Public Comment Themes
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Innovation
• More data sharing increasing innovation.
• Oversharing suppresses innovation.
Notable Public Comment Themes
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Unintended Consequences
• Open-ended rules will perpetuate information blocking.
• Open-ended rules impose too high a burden on recipients of requests
for EHI.
• “Transformed” data made available at cost.
Notable Public Comment Themes
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Cost Recovery
• Reasonable cost method represents unlawful cost caps, and free
market should decide. Allow for profits.
• Cost recovery is appropriate for sharing of EHI.
Notable Public Comment Themes
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42. • Introduction
• Interoperability
• 21st Century Cures Act & Proposed Rule
• Examples of Information Blocking Practices
• Proposed Exceptions to Information Blocking
Practices
• Notable Public Comments
• How Healthcare Organizations May Be
Affected
Agenda

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How would you describe your organization’s readiness to comply with
the Cures Act interoperability and information blocking provisions?
1. Familiar with the requirements but have not prepared to comply –
54%
2. Outlined steps needed to comply – 18%
3. Ready to comply now or within 6 months – 29%
Poll Question #3
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• It’s going to take awhile. The comments need to be considered and
the final rule needs to be written.
• But it may not be as long as some other regulations given the urgency
expressed by ONC.
• The requirements may change.
Things to Consider When Preparing for the Final
Rule on Information Blocking
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• Will your organization be directly covered by the final rule?
• Consider where requests for EHI may come from.
• Or consider from whom you will request EHI.
• Is your database architecture set up to implement the likely
standards? (FHIR, APIs, USCDI) And what are the likely gaps?
• Who can help you?
Things to Consider to Start Preparing
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Sept. 10-12, Salt Lake City, Grand America Hotel
• National Keynotes
• Digital Innovation Showcase
• 28 Educational, Case Study, and Technical Breakouts
• 24 Analytics Walkabout Projects
• Machine Learning Marketplace
• Networking (bringing back ”Braindate”)
• CME Accreditation for Clinicians
• 5-Star Grand America Hotel Experience
• 96 Total Presentations
Healthcare Analytics Summit 19
45

47. Questions

48. Thank
You!