Cures Act Summary


Achieving Interoperability: The 21st Century Cures Act

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Introduction

The 21st Century Cures Act (Cures Act) is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

What does this mean for your facility?

Learn more about how this Act will impact your hospital, and how MIC’s Sickbay™ platform can help you stay compliant with minimal overhead and extraneous resources.

Background

The 21st Century Cures Act, signed into law on December 13, 2016, is designed to provide individual patients and their health care providers with free and fast accessibility to electronic health information (EHI) of the patient’s core data. Enforcement is assigned to the Office of the National Coordinator (ONC) for Health Information Technology, which implements the first stage of The Cures Act on April 5, 2021. Entities responsible for i mplementation of The Cures Act include healthcare providers, certain health information technology networks, and health information exchanges.

1

Requirements for Hospitals

The Cures Act has multiple features, but two primary areas of emphasis for hospitals are: 1) information blocking, and 2) interoperability. Under the Act, hospitals are required to prevent information blocking of EHI between its vendors, and to provide interoperability throughout its patient workflow for streamlined exchange of EHI.

Information Blocking

Information blocking is a practice that “is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” The hospital is a primary conduit for EHI and has central responsibility in ensuring the efficient flow of information between and among its providers and patients. While there are exceptions for reasonable and necessary activities to protect EHI, minimize security risks, and prevent harm, the primary role of the hospital is to manage the patient’s data for appropriate, efficient, and economical care.

Interoperability

Under The Cures Act, interoperability applies to, “all electronically accessible health information” that can be accessed, exchanged and used for the purpose of delivering patient care.” In practical terms, this means all healthcare vendors in the patient care workflow must facilitate access to the patient data collected on their platforms.

The Cures Act is meant to hold hospitals accountable for providing easy access to patient-centered data. Failure to comply with The Cures Act can result in serious federal penalties of up to $1 million per incident.


Deadlines to Know

On July 31, 2021 interoperability enforcement begins. Beginning in early 2021 EHI core data elements are phased in for enforcement, with inclusion of all required EHI data by October 6, 2022.

2

How Does Your Hospital Comply?

Hospitals must ensure their patient data sources are accessible and open for health information exchanges, interoperability, and easy patient access. This can be a daunting task, as hospitals often utilize numerous third-party vendors to monitor and maintain patient data. These third party vendor products are usually not accessible from one vendor platform to another. It is noteworthy that third-party vendors can charge limited fees to defray actual costs for access by the hospital so that the hospital’s other vendors can connect into the workflow for cost-effective delivery of services.

Under The Cures Act, hospitals must ensure their vendors do not engage in information blocking of EHI with their other vendors in the patient care workflow. The Cures Act is now in the arsenal of “Applicable Laws” terms in vendor contracts by which hospitals can direct their vendors to meet the new standards.

This means hospitals need to have contracts in place with each vendor to ensure reasonable and proper interoperability is required from one vendor to another, ultimately creating an accessible flow of patient data from patient to medical device[s] to clinician to medical record.

3

How MIC’s Sickbay™ Can Help

MIC’s Sickbay™ is helping to ensure that hospitals and healthcare systems have access to all the data they need, in whatever format is needed.

- Sickbay™ can integrate directly with the hospital’s existing infrastructure to receive and send data from biomedical devices and systems in standardized data formats and terminologies.

- Sickbay™ also offers open APIs and SDKs so hospitals are able to convert aggregated data into any portable format, system, or platform desired by the institution. This includes access to near-real-time physiologic waveform and other device data from networked and non networked devices that has traditionally never been available.

- Sickbay™ has been proven to provide hospitals with an unified platform architecture that solves multiple clinical and operational initiatives, allowing hospitals to avoid the cost of single-point solutions to reduce capital and operational costs, and also leverage that data to increase revenue and improve operational efficiencies.

Conclusion

For More Information

MIC is committed to breaking down the silos and unlocking data that has never been available before. This allows healthcare facilities to be compliant with the latest standards, such as the Cures Act. Data also empowers members of the healthcare team to make data-driven decisions and save more lives. MIC is helping to challenge the current status of patient monitoring and analytics, and create a new standard of care.

Click here to learn more about Sickbay and MIC. Check out our blog and resource center for additional articles, videos, news and white papers.

If you have a question or need more help with the Cures Act, data access, and workflow challenges, fill out the form to the right and a member of the MIC clinical consulting team will be in touch within 48 business hours.


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MIC’s FDA-cleared software-based Sickbay™ platform is challenging the world of patient monitoring and analytics to create a new standard of data-driven care. This is accomplished by automating the collection of patient data from the bedside to bring it to care teams wherever they are so they can:

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Together, we believe we can change the face of medicine, save more lives, and help care teams get back to focusing on patients instead of data. Click here to learn more about Sickbay™ and MIC. Check out MIC's blog and resource center for additional articles, videos, news and white papers.

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Need More Help?

MIC is committed to empowering all members of the care team to save more lives by unlocking data in ways that have not been available before.

If you need more information or help with other data access and workflow challenges, send us your information today. A member of the MIC clinical consulting team will be in touch promptly.

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