80 megabytes. That’s the amount of data generated in imaging and electronic health records (EHRs) for a single patient each year. While that number may seem staggering, it’s just the tip of the iceberg. With the healthcare industry currently generating 30% of the world’s data volume, RBC Capital Markets projects that by 2025, the compound annual growth rate of data for healthcare will reach 36% – increasing at a faster pace than financial services, manufacturing, and media and entertainment industry sectors.
This data is valuable to patients who want to have full access to their records and understand their healthcare costs, as well as for providers who want to deliver effective care and have patients experience optimal outcomes, thus overall improving population health.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Even though the healthcare industry generates so much data, however, about 80% of that remains unstructured and unused after it is created. Tremendous insights are left undiscovered as a result, primarily because interoperability of the various digital systems and data sharing among organizations and patients has not historically been common practice.
That’s where the 21st Century Cures Act and its subsequent rulemaking come in. When thinking of large healthcare laws like this one, multiple agencies within the U.S. Department of Health and Human Services have roles in implementing them. When it comes to implementing the Cures Act, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) each must administer the law’s requirements. Therefore, each agency has released its own final rule for their own jurisdictions.
Signed into law in late 2016, the Cures Act took steps to increase choice and access for patients and providers. Beyond spurring innovation in drug and medical device development, accelerating research into serious diseases and addressing our country’s opioid and mental health crises, the law also seeks to ease regulatory burdens associated with use of EHR systems and health information technology. With provisions focused on advancing interoperability and eliminating information blocking, a major goal of the Act was to give patients and healthcare providers secure access to health information. It also seeks to foster greater innovation and competition, encouraging development of new applications that give patients greater choice in their healthcare.
Ambulatory care practices must be familiar with the final rules, as they both require compliance with interoperability, patient access and prohibiting information blocking. Since ONC is the certifying body for EHRs, providers must be prepared to transition to a new “Cures Edition” version of its software before the end of 2022. The CMS final rule focuses primarily on payers, requiring them to also focus on interoperability and increased patient access.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Now let’s take a look at each rule more closely:
ONC final rule
Even though information blocking is the primary focus of the ONC final rule, it also requires that developers certified by the ONC Health IT Certification Program must have standardized Application Programing Interfaces (APIs) and implement Fast Healthcare Interoperability Resources (FHIR) technology, all of which will enable individuals to securely and easily access structured electronic health information. These advancements will only make information sharing easier.
Most importantly, for practices, this rule began prohibiting information blocking practices by providers, health IT developers, health information exchanges (HIEs) and health information networks, effective April 5, 2021. Currently there are no “disincentives” for providers engaging in information blocking practices, but the Office of the Inspector General is expected to release an enforcement rule later this year.
While information blocking prohibition is currently in effect, API and FHIR implementation is not required by the ONC until the end of 2022. This is the reason providers must upgrade to Cures’ required versions that have these new components.
CMS final rule
The CMS final rule also focuses on API interoperability, requiring federal payers to make provider directory information publicly available. Specifically, it encourages interoperability and patient access to health information by liberating patient data using CMS authority to regulate Medicare Advantage, Medicaid, Children’s Health Insurance Program and Qualified Health Plan issuers on the Federally-facilitated Exchanges.
Two APIs of note under the CMS rule are:
- Patient Access API, which gives patients access to claims data, encounter information and cost.
- Provider Directory API, which, by making provider directory information broadly available using an API would allow payers to encourage innovation among third-party app developers, who could access the information to create new services.
Both Patient Access and Provider Directory APIs were initially required by January 1, 2021, however the COVID-19 public health emergency delayed implementation of rules until July 1, 2021.
Core takeaways for today’s providers
Spurred on by the Cures Act, there have been significant changes in the way electronic health information is accessed and shared. Practices and providers must be familiar with the final rule so they can maintain compliance and ensure that they’re not intentionally or inadvertently blocking information – and proactive steps can be taken by keeping these things in mind:
- Not all information has to be shared — HIPAA still matters! The ONC has considered and published eight exceptions to information blocking that should be reviewed by providers to know what they can still do to protect patient privacy — and how they can provide information that may not be captured in their EHR today. Helpful websites such as www.healthIT.gov/curesrule are valuable for learning more.
- Establishing a documentation system for when patients request their information could be useful. Notate when a request is made for information, and how you provided it. If you did not provide the information, document which of the eight exceptions you think applied.
- You’ll need to be on a Cures-compliant EHR product before December 31, 2022 – staying aware of how and when your EHR provider plans to roll out their upgrade plans will help you plan.
Preparedness will be particularly important now, as the agencies move from finalizing the rules to stepping up enforcement for non-compliance.
Photo: NicoElNinom, Getty Images
Stephanie Jamison has over 15 years of experience in healthcare and health IT public policy. She currently serves as Greenway Health’s Regulatory Affairs Director, a position she has held since January 2019. In this role, she also represents Greenway on the Electronic Health Record Association (EHRA) as a member of the Executive Committee, which serves as the collective leadership voice for the association. Prior to joining Greenway, she held various public policy and regulatory affairs roles with WellCare Health Plans, HIMSS, the National Governors Association, among others.
