The U.S. Government has improved health data interoperability and introduced transparency in healthcare pricing through new FDA and CMS policies. As a result, the healthcare industry expects medical technologies and digital health tools to undergo innovations that support this vision. Let’s cover how to meet the complex health data interoperability regulations
There has recently been a significant investment in digital health platforms, which is fantastic to see! In the last few months, the laws and regulations have been evolving to accommodate modernized care delivery. This article will focus on a few critical parts of these regulations and show you where the future is heading.
The 21st Century Cures Act and the CMS Interoperability and Patient Access Final Rule is crucial legislation. Meant to improve health information exchanges in healthcare by establishing standards for access through precision medicine initiatives.
CMS Interoperability and Patient Access Final Rule
The CMS Interoperability and Patient Access final rule includes policies that impact various stakeholders. The law ensures that all health care providers have access to information to treat patients following federal and state laws and regulations.
Specifically, the rule includes standards for certification, implementation, and testing of electronic health records certified to the electronic health record (EHR) certification and implementation standards of the Office of the National Coordinator for Health Information Technology (ONC).
CMS Interoperability and Patient Access Final rule includes seven requirements that healthcare organizations need to comply with.
1. Patient Access API
- CMS-regulated payers must provide patients with their providers’ clinical information after paying their deductible.
2. Provider Directory API
- Except for QHP issuers on the FFEs, CMS-regulated payers need to publicly make their Provider Directory Information available using a standards-based API.
3. Dual Eligible Data Exchange Frequency
- The rule requires all states to increase the frequency of federal-state data exchanges for dual eligible individuals.
4. Payer-to-payer Data Exchange
- The rule requires CMS-regulated payers to allow the payer to payer exchange patient health data at the patient’s request.
5. ADT (Admission, Discharge & Transfer) Event Notification
- CMS regulated payers must send out ADT Event Notifications to all applicable healthcare providers.
6. Provider Digital Contact Information in National Plan and Provider Enumeration System (NPPES)
- CMS will publicly report the names of healthcare providers who do not list or update their contact information.
7. Public Reporting and Information Blocking
- CMS will publicly report the providers who engage with information blocking. Healthcare organizations must have policies and procedures in place to ensure that information blocking is prevented.
The CMS Interoperability
The CMS Interoperability Patient Access Final rule is likely to be implemented differently by each state and commonwealth, but the intention behind it is the same.
Healthcare agencies, payers, and providers who are subject to this rule will all have their own ways of implementing the requirements that they need to follow to meet the standards set forth. In this case, they need to take a pragmatic approach to meet the criteria immediately.
Making health data available through healthcare APIs will help those who need health care data. Patients can make more informed decisions about their health. Providers can also better use their allocation for health funds across a broader range of programs that directly benefit patients’ access and overall wellbeing.
21st Century Cures Act
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is an effort to usher in changes that will help make medicinal products more easily developed and brought to the marketplace more rapidly.
It’s designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.
The law also allows patient-reported outcomes to form the primary basis of establishing that a device is safe and effective. It tasks the agency with developing standards to enable patients, consumers, and other interested parties more timely access to information about device safety, performance quality, and effectiveness after a device is placed on the market.
Cures Act Programs
The Cures Act gives the FDA more money and resources to help them find new ways to recruit scientists, doctors, and other specialists to help with their research and development teams.
The act also allows them faster access to clinical trial volunteers who will assist in various clinical trials for people looking for a cure of disease or treatment for debilitating conditions.
- Regenerative Medicine Advanced Therapy (RMAT) deals exclusively with the health and safety of youth in regenerative medicine. That being said, it also offers an expedited system that’s geared towards biologics. This is excellent news for all kids suffering on a daily basis when it comes to serious ailments.
- The Breakthrough Devices program is designed to make new and improved devices available to physicians, patients, and their caregivers more quickly than through the standard regulatory review process. The FDA works with sponsors of qualifying devices to facilitate the development, review, and potential approval of breakthrough devices through this program.
Meeting Health Data Interoperability Regulations
The 21st Century Cures Act and CMS interoperability set a clear intention to help people get the healthcare they need. They are meant to streamline access for patients and more effectively share health-related information between different healthcare providers. These regulations strive to help people make better decisions about their own health.
With these new rules, developers have a lot of opportunities to build apps and make sure that patients can communicate with their providers. It’s also an excellent opportunity for payers to capitalize on the fact that there are a lot of different devices.
Strive for the Development of User-Friendly Applications
Trying to meet regulations while also having a healthy and robust business means that you will have faced countless technical challenges. Along with other obstacles presented by IT, business, clinical, and customer experience stakeholders. It might get tricky at times to keep all of these paths of progress open and insight.
Opportunities like this don’t come often, so developers need to be interested! Sometimes, there are other more complex systems, but consumers tend to gravitate towards apps that are easy to understand. Hence, developers have an essential role in making the user experience of medical apps easy and self-explanatory.
While the work is stressful, it’s rewarding to look at the finished product, to be able to say you made it, and to be proud that you helped with health care reform.
Comply with Current Health Data Interoperability Standards
It’s an excellent opportunity for the healthcare sector to display its confidence in the industry by striving to meet and even exceed current minimum compliance standards.
This can make it possible for organizations willing to go above and beyond what is necessary out of duty alone to enjoy a real advantage in terms of loyalty, increased revenue, and improved safety conditions. It also plays a positive role in the overall improvement of our national healthcare system.
These new rules allow patients to see their health data in a convenient and private format. We are providing payers with higher standards while protecting patient privacy by requiring secure access to personal records for their convenience. These changes will result in evidence-based outcomes for improved patient care and cost-efficiency.
Always think ahead.
As you may know, time is of the essence in any endeavor, and business is certainly no exception! We urge you not to let that keep you from thinking ahead to ways that an otherwise burdensome regulatory activity can benefit your organization.
