MedCity Influencers, Opinion, Health Tech

Leveraging the cloud to meet the ONC final rule compliance deadline

The deadline for ONC’s final rule on interoperability and information blocking is upon us. The time is past due for health providers, networks, and vendors to evolve their IT infrastructure — and the cloud really is the only way forward.

cloud, patient management, patient experience, clinical trials

The postponement of a certain April 15 deadline has many Americans breathing a sigh of relief. But U.S. healthcare organizations (including providers, networks, health IT developers, and health information exchanges) will have no such luck with a different April deadline.

Compliance comes due on April 5 for the 21st Century Cures Act Office of the National Coordinator (ONC) Final Rule.

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The Cures Act ONC Final Rule
Last spring, the US Department of Health and Human Services issued what’s known as the “ONC Final Rule” outlining technical implementation details for the 21st Century Cures Act, clarifying interoperability requirements and limiting information blocking practices to improve both patient information access and healthcare data flow.

Due to the Covid-19 pandemic, the ONC provided a little leeway and extended compliance timeframes for certification.

But that extension ends on April 5. According to the National Law Review, as of April 5, covered actors should ensure that:

  • They have configured patient portals to provide electronic health information (EHI) to patients without unnecessary delay.
  • They have updated all release of information policies.
  • They have assessed their contracts and arrangements involving EHI with any third parties to comply with information blocking prohibitions.
  • They have prepared real-world testing plans, application programming interfaces (APIs) with new HL7 FHIR capabilities, EHI data export and other capabilities targeted for 2021 and 2022.
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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Most impacted organizations are working long and hard to get it all done on time, but it isn’t easy. Here’s why.

Interoperability and Information Blocking
The Final Rule lays out healthcare IT compliance certification conditions that include support for standards and published APIs that allow health information “to be accessed, exchanged, and used without special effort,” and “access to all data elements of a patient’s electronic health record to the extent permissible under applicable privacy laws,” as explained in the Federal Register.

The goal is true healthcare data portability nationwide with agile and standardized data exchange processes. The specific computing standards supported must include:

Limits on information blocking and anti-competitive practices are also outlined in the Final Rule — and the feds are serious about getting information moving. With very few exceptions, patients make the final decision on what applications obtain access to their electronic health information, which “includes, but is not limited to” a long list defined in 45 CFR 160.103 that “may also be provided, directly from an individual, or from technology that the individual has elected to use, to an actor covered by the information blocking provisions.”

It’s All A Good Thing, But…..
Enforcement of the ONC Final Rule will result in improved information exchange via standards-based API’s between providers, payers, and registries and deliver more control and transparency for patients, in addition to supporting better public health reporting and care quality improvement.

But the actual process of implementation — particularly the necessity of moving away from legacy frameworks and environments — is challenging.

Today, an astounding volume of healthcare data is continuously created from an ever-expanding array of sources – electronic medical records, highly detailed imaging systems, telemedicine audio/video sessions, implantable devices, activity monitors…you name it. Collecting, normalizing, storing, managing, and working with these enormously large data sets is unimaginably complex — and it requires a lot of computing power.

But most legacy health IT systems use a variety of incompatible (often proprietary) technologies that cannot play nicely with others and tend to lock data into siloed formats. The industry has traditionally relied on licensed “integration engines,” large dev teams, and large server farms for difficult integration work. But this arrangement is prohibitively time consuming and costly for building, maintaining, and scaling systems that must meet multiple implementation guidelines at varying levels of maturity for each resource specification on humongous (and growing) data streams and sets.

Even with unlimited resources and unlimited staff (not exactly hallmarks in healthcare), yesterday’s IT strategies simply don’t fly in modern conditions — and they certainly aren’t up to the challenges of healthcare’s future, much less today’s FHIR formats and Final Rule requirements.

Solution = Cloud
The difficulties and expenses associated with modern health data integration, management, and compliance can be overcome using cloud-based infrastructure. Many healthcare organizations have embraced its power to meet Final Rule requirements and future-proof their IT. It’s the only feasible solution.

Healthcare information interoperability services can be set up and run in the cloud in a fraction of the time/cost needed for traditional storage systems that require the procurement, evaluation, racking/stacking of physical servers and databases, and configuration for data ingestion/export — a process that can take months. Cloud-native solutions can be deployed and scaled in moments with a consolidated data environment feeding multiple data stores.

Using cloud power, healthcare organizations can instantly spin up computational resources as demand increases and spin them down when no longer required or desired. Costly resource procurement is a thing of the past with the cloud’s pay-for-use model. And cloud-native architecture provides data access through non-proprietary, open-source tools — meaning no more data format siloes or contractual vendor lock ins.

The Future is Now
The ONC Final Rule deadline is upon us. American health data needs to flow safely and securely. More portable and patient-centric healthcare information technology is required, and interoperability is the mandate moving forward.

The time is past due for health providers, networks, and vendors to evolve their IT infrastructure — and the cloud really is the only way forward.

Photo: mathisworks, Getty Images

I am the Founder and CEO of Cloudticity. I spend my days thinking about how to help the healthcare industry best leverage cloud technology to enable them to help people live healthier lives. I have spent the last 30 years navigating the technology industry. Prior to Cloudticity, I was brought in as the chief operating officer at ePrize; I turned around a failing company that was eventually sold for a fourfold return on the initial private equity investment. Before ePrize, I spent eight years at Microsoft, first as chief technology officer for the US central region, then running the global business unit that oversaw General Motors (Microsoft’s second-largest customer), growing that account from $20MM to over $100MM in three years. Prior to Microsoft, I spent nearly a decade in the technology consulting and startup industry. I hold all the core five AWS certifications.

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