The 21st Century CURES Act gives patients access to reading their health records. It enables immediate access to the patient’s notes, tests, diagnoses and treatment.
This is different from the access with HIPAA which can take longer to obtain.
In 2024, proper documentation in Electronic Health Records (EHRs) has become even more important than ever. Clinicians are advised to adhere to the following recommendations:
Chart as if the patient is reading your words.
Chart how you want someone to talk to you.
Chart in a way that’s encouraging and shows progress.
Try to keep the notes consistent and OBJECTIVE.
Avoid things that are inappropriate, rude, catty, or disgusting.
Please don’t forget about the power of social media. If you write something bad in the patient’s chart and it gets a screenshot or ends up on Twitter or Facebook, it can be a colossal disaster. You want the medical record picture to be GOOD. That’s why notes should be written or dictated in a way that’s empathetic, encouraging, and positive.
Avoid bad habits. Good charting could be a great lifesaver, especially in lawsuits.
If you choose your words wisely before entering them in EHRs, you can avoid bigger problems.
EHR Services
EHRs have evolved to offer a unified, real-time perspective of a patient’s health history. They facilitate data exchange, and they ensure that all patient information is readily accessible to authorized healthcare professionals.
Accessing, updating, and sharing patients’ medical information seamlessly across various providers, clinics, and hospitals is essential for delivering high-quality, coordinated care.
EHR systems and Interoperability
EHR systems have become multifaceted and interconnected, thereby revolutionizing data exchange and interoperability.
Standardization of Data: EHR systems are expected to adopt standardized coding and terminologies like SNOMED CT, LOINC, and CPT.
Interoperability: EHR systems are projected to actively contribute to improved connectivity. This enables integration with other health information systems, which facilitates access to external data sources and promotes informed decision-making.
Cloud-Based EHRs offer scalability, accessibility via the internet, and cost-effectiveness.
Patient Portals in EHRs will empower patients to access their health information, schedule appointments, and communicate with healthcare providers.
The Core Features of EHRs are:
What do EHRs offer in 2024?
Centralized Patient Data Repository. EHRs consolidate patient information into structured formats, providing authorized users with a single, comprehensive source.
Streamlined Access to Patient Data. EHRs break down geographical barriers by facilitating swift access to patient records regardless of location, as in telemedicine.
Data Standardization: As healthcare providers adopt common data exchange standards like Fast Healthcare Interoperability Resources (FHIR), EHRs serve as bridges between different systems, thereby facilitating seamless data flow.
Ensuring Secure Data Sharing: EHR systems use encryption, user authentication, and audit trails to protect patient data during exchanges.
Enhanced Communication: EHRs foster effective communication among healthcare professionals through features like secure messaging, alerts, and notifications.
Improved Patient Engagement: EHRs contribute significantly to patient engagement by integrating patient portals. This empowers patients to access their medical records, test results, diagnoses and treatment plans.
What are the persistent challenges facing EHRs in 2024?
Data Privacy and Security: EHR systems must enhance security measures to thwart data breaches and unauthorized access. Ensuring patient data privacy and security is essential.
Data Ownership and Control: The issue of determining data ownership and control continues to be contentious.
Economic Considerations: Smaller practices may face challenges in implementing and maintaining EHR systems with robust data exchange capabilities.
Standardization Challenges: Ongoing efforts are essential to establish common standards, facilitating seamless data exchange.
Interoperability Across Specialties: EHR systems that are tailored to specific specialties within health services may not seamlessly connect with each other. EHR platforms must be interoperable to facilitate seamless data exchange among healthcare providers.
Algorithmic Bias: AI algorithms can perpetuate existing biases in healthcare. Ensuring that AI is developed and deployed ethically and responsibly is crucial.
What are the Key Trends and Developments in EHRs in 2024?
Widespread Adoption of Fast Healthcare Interoperability Resources (FHIR) may be adopted as a common data exchange standard.
Blockchain-based solutions for Data Security may be used to enhance data security and integrity.
AI Integration: EHR systems will increasingly integrate Artificial Intelligence (AI) capabilities to process extensive datasets, detect patterns, and support healthcare professionals in making more precise diagnoses and treatment choices.
Incorporating Internet of Things (IoT) devises such as wearable health monitors and smart medical equipment. This integration enables continuous patient monitoring and provides valuable insights into individual health conditions.
Improved Patient Portals which will become more sophisticated, offering patients greater control over their healthcare.
Expanding Telemedicine Capabilities: by facilitating remote consultations and data exchange between patients and healthcare providers.
Advanced Analytics and Reporting. This empowers healthcare professionals to access real-time information, generate comprehensive reports, and identify trends to enhance both patient care and operational efficiency.
How will AI integration help EHRs?
AI can Streamline Administrative Tasks. For example:
AI-powered chatbots can handle routine tasks like scheduling appointments, answering patient questions, and processing insurance claims.
Natural language processing (NLP) can automate the creation of clinical notes and reports, freeing up physician time for patient care.
AI can Improving Clinical Decision-Making. AI can analyze medical data to identify trends, patterns, and potential risks. This information can develop personalized treatment plans, reduce medication errors, and predict patient outcomes.
AI can Enhance Patient Engagement. AI-powered virtual assistants can provide patients with personalized health information and reminders. Chatbots can offer support and help patients manage their chronic conditions.
AI can Optimizing Revenue Cycle Management. AI can accurately identify and code diagnoses and procedures, reducing claim denials and improving reimbursement. Predictive analytics can forecast patient needs and resource utilization, enabling more efficient resource allocation.
AI can Drive Innovation and Research. AI can analyze EHR data to identify potential areas for research and development. This data can provide information needed to help develop new drugs, therapies, and diagnostic tools.
The 21st Century Cures Act (Cures Act).
On December 13, 2016, President Barak Obama signed the 21st Century Cures Act (Cures Act). It authorized $6.3 billion in funding.
The goals of the legislation were to help accelerate research in medical product development, and to bring new artificial intelligence innovations and advances to patients who need them faster and more efficiently. The legislation wanted to ensure that the U.S. remains a global leader in medical innovation and keeps the jobs here at home.
Interestingly, the Cures Act allows clinical researchers to waive the requirement for "informed consent" in cases where clinical testing of drugs or devices "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.” One example is placing a high-tech bandage that monitors blood flow on unconscious patients.
The Cures Act Guidelines
The Cures Act guidelines apply to Health care providers, Health information networks and exchanges, and Health IT developers of certified health IT (e.g., electronic health record vendors).
Since April 2021, providers must release information covered in the United States Core Data for Interoperability (USCDI) USCDI Version 1 if they have the technical capability to do so.
Since December 31, 2022, all Certified Health Information Technology (i.e., EHR vendors) must have the new HL7 FHIR API capability and make information in USCDI Version 1 available to their customers. If providers do not have the technical capability to make information outlined in the USCDI Version 1 available, they can claim an exception to the Cures Rule.
Since October 6, 2022, the definition of electronic health information (EHI) in the 21st Century Cures Act has expanded beyond the United States Core Data for Interoperability (USCDI) Version 1 to all electronic Protected Health Information (ePHI) that a patient has the right to access under the Health Insurance Portability and Accountability Act (HIPAA).
Background: In the HIPAA Privacy Rule, protected health information (PHI) is considered any identifiable health information used, maintained, stored, or transmitted by a covered entity.
A covered entity health care provider is one that bills an insurance company for services provided to any patient. Covered entities include health plans and healthcare clearinghouses. Note: The Information Blocking Rule also applies to some organizations that are NOT covered entities; however, it is not applicable to all covered entities
Since October 6, 2022, instead of being limited to the USCDI Version 1, the definition of EHI now includes all information in a Designated Record Set, as defined under HIPAA.
In other words, EHI will not be limited to the specific data classes listed in the USCDI and will also consist of medical and payment records about a patient and any information of a type that may be used to make decisions about individuals, including patients. For actors covered by the information blocking rules, all ePHI in a Designated Record Set is considered to be EHI and subject to those rules.
EHI (Eletronic Health Information) includes:
Medical records and billing records about individuals maintained by or for a covered healthcare provider.
Enrollment, payment, claims adjudication, and case or medical management record systems; or
Other records that are used, in whole or in part, by or for the covered entity to make decisions about individuals.
More information about EHI and ePHI can be found at HealthIT.gov, and downloaded as PDFs:
There are complex situations in which information can be blocked—and these are called Exceptions. Unless one of the Exceptions applies, clinical notes must not be blocked.
Note: A group called actors are referred to throughout the rule. Actors include:
Health care providers (including physicians, physician assistants, nurse practitioners, nurses, social workers, chaplains, and therapists)
Health information networks or health information exchanges
Health IT developers of certified health IT (e.g., electronic health record vendors)
Information Blocking Exceptions
Featured below are eight exceptions to information blocking outlined by the final rule of the CURES Axt. The Exceptions fall into two categories (source).
Category 1. Exceptions that involve not fulfilling requests to access, exchange, or use electronic health information (EHI)
Preventing Harm Exception: It will not be information blocking for an actor (Healthcare professional) to engage in practices that are reasonable and necessary to prevent harm to a patient or another person, provided certain conditions are met.
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.
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.
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.
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.
Category 2. Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI
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.
8. 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.
Details regarding conditions that must be met to meet these exceptions can be found on the ONC website.
Types of Clinical Notes that must be Shared
There are eight (8) types of clinical notes that must be shared as outlined in the United States Core Data for Interoperability (USCDI). They include:
Consultation notes
Discharge summary notes
History & physical
Imaging narratives
Laboratory report narratives
Pathology report narratives
Procedure notes
Progress notes
Click Here to View the full USCDI
U.S. Federal Rule Mandates Open Notes.
As of April 5, 2021, the federal rule on Interoperability and Information Blocking is the national policy that requires healthcare providers to give patients access to all of the health information in their electronic medical records “without delay” and without charge.
As of April 2021, “blocking” patients from their own health records is against the law and may result in fines for hospitals and doctors. Find out how the Information Blocking Rule and Cures Act impacts patients at link: WhereIsMyMedicalRecord.org.
As of November 2023, the Department of Health & Human Services (HHS) proposed ‘Disincentive’ penalties for Information-Blocking Providers. This proposed rule was posted to the Federal Register and is taking comments until 11:59 p.m. ET on January 2, 2024. The rule will affect physicians who participate in the Medicare program.
Some clinicians report “dumbing down” their language, but they find themselves using fewer medical abbreviations and trying to avoid language that could appear judgmental to patients. Other clinicians report modulating their practice such that they become “teaching notes.”
Patients do not generally expect doctors to write notes in layperson language, and more than 90% in one large study report understanding their notes well. Patients are not bothered by terms they don’t understand, and they are happy to research those terms. They feel that reading notes helps them prepare more focused questions for clinicians. Overall, they express considerable enthusiasm for having a window into more information about their health.
Types of Clinical Notes that are Protected
There are a few types of clinical notes to which the information blocking rules do not apply. Denying access to the following types of information does not constitute information blocking.
Psychotherapy notes as defined by HIPAA that are separated from the rest of the individual’s medical record. These notes must be recorded (in any medium) by a mental health professional documenting or analyzing the contents of conversation during a private, group, joint, or family counseling session. Note: All behavioral health professionals are required to share their notes regarding medication prescription and monitoring, counseling session start and stop times, the modalities and frequencies of treatment furnished, results of clinical tests, and any summary of the following items: diagnosis, functional status, the treatment plan, symptoms, prognosis, and progress to date.
Forensic EHI. Information compiled in reasonable anticipation of, or use in a civil, criminal or administrative action or proceeding. |
EHI that was obtained from someone other than a health care provider under a promise of confidentiality, where the requested access would be reasonably likely to reveal the source of the information.
Conclusion
The 21st Century Cures Act was signed into law by President Obama in 2016 with overwhelmingly bipartisan support. Information sharing is central to the Cures Act Final Rule released by the Office of the National Coordinator (ONC) for Health Information Technology (ONC) in 2022.
Some refer to this as the “information sharing rule.” It mandates that patients have rapid, free and full access upon request to test results, medication lists, referral information, and clinical notes, all in electronic formats.
Some refer to the Cures Act Final Rule as the “Open Notes Rule.” This is inaccurate. Although ONC strongly supports the concept of ‘open notes’, and work by the OpenNotes movement headquartered at Beth Israel Deaconess Medical Center, the Cures Act Final Rule and ‘open notes’ are not synonymous. The Rule extends well beyond clinical notes.
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