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04/06/2021    Michael Brody, DPM

The New 21st Century Cures Act

The New 21st Century Cures Act takes effect April
5th. Are you ready?

Let’s look at the rule and make sure we understand
what we need to do in order to be in compliance.
What are the Goals of the 21st Century Cures Act?

• Make patient data requests easy and inexpensive
• Allow patients, doctors, and healthcare systems
to benefit from a vibrant application marketplace.
• Improve patient safety
• Prevent information blocking

Let’s look as some situations you may face and see
what you need to do.

If you have an existing contract, agreement or
other arrangement that prohibits you from sharing
data, then that agreement may put you into
violation of the information blocking provisions of
the 21st Century Cures Act.

What to do?

Review all of your contracts with your EHR and
digital health vendors and make sure there are no
provisions that conflict with the new rule. If you
are not sure, please consult with an attorney.

What if you are not using certified health
information technology (A certified EHR).

The 21st Century Cures Act is not specific to any
product. The rule applies to all information that
you hold, whether it be in a Certified EHR, an EHR
that is not certified, your billing system, your
digital imaging system, or even word processing
files. It is all subject to the rule.

What about paper records?

The 21st Century Cures Act is about electronic
information. For details on Paper records you need
to refer to the HIPAA Right of Access Rule.

Do you need to have your patient portal turned on?
This is an interesting question.

The short answer is YES. But you do not have to
have it turned on until you get a request for
patient information through the portal. The moment
you get such a request it needs to be turned on.
If it takes ‘too long’ to turn on the portal and
that results in a delay that the government
believes it not reasonable you may be found to be
in violation of the Cures Act. It is in your best
interest make sure it is turned on now rather than
having to scramble the moment you get your first
request.

How quickly do I need to make lab results available
through the portal?

You need to make lab results available as soon as
you get them unless you can demonstrate that
releasing the lab results may result in patient
harm, this is one of the exceptions to the Cures
Act. If you make such a determination, it is vital
that you document this decisions process so that
you can defend yourself in and investigation.

What about “Draft Notes” and incomplete lab
results?

Draft notes and lab results that are not finalized
MAY not be appropriate to disclose or exchange due
to the incomplete nature of the results. But if
the information in the Draft note or incomplete lab
result was used to make a medical decision then it
must be disclosed.

Are there any exceptions to the Information
Blocking provision of the Rule?

Yes, there are eight (8) exceptions to the rule:

1) Preventing Harm Exception It will not be
information blocking for an actor to engage in
practices that are reasonable and necessary to
prevent harm to a patient or another person,
provided certain conditions are met.

2) Privacy Exception It will not be information
blocking if an actor does not fulfill a request to
access, exchange, or use EHI in order to protect an
individual’s privacy, provided certain conditions
are met.

3) Security Exception It will not be information
blocking for an actor to interfere with the access,
exchange, or use of EHI in order to protect the
security of EHI, provided certain conditions are
met.

4) Infeasibility Exception It will not be
information blocking if an actor does not fulfill a
request to access, exchange, or use EHI due to the
infeasibility of the request, provided certain
conditions are met.

5) Health IT Performance Exception It will not be
information blocking for an actor to take
reasonable and necessary measures to make health IT
temporarily unavailable or to degrade the health
IT's performance for the benefit of the overall
performance of the health IT, provided certain
conditions are met.

6) Content and Manner Exception It will not be
information blocking for an actor to limit the
content of its response to a request to access,
exchange, or use EHI or the manner in which it
fulfills a request to access, exchange, or use EHI,
provided certain conditions are met

7) Fees Exception It will not be information
blocking for an actor to charge fees, including
fees that result in a reasonable profit margin, for
accessing, exchanging, or using EHI, provided
certain conditions are met.

Licensing Exception It will not be information
blocking for an actor to license interoperability
elements for EHI to be accessed, exchanged, or
used, provided certain conditions are met.

For more details on the exceptions visit
https://www.healthit.gov/cures/sites/default/files/
cures/2020-03/InformationBlockingExceptions.pdf

Michael Brody, DPM, Commack, NY

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