On March 9, 2020, the U.S. Department of Health and Human Services (HHS) finalized and published two transformative rules that will give patients unprecedented safe, secure access to their health data. Combined with the Sobczak Law’s two 2019 wins at the Massachusetts Appeals Court, this makes it crystal clear that patients’ and consumers’ timely, affordable, and safe access to their healthcare data and information remains secure and enforceable right.
The two new rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act (Cures Act).
As part of the new rules it was clarified that the law requires the electronic health records (EHR) systems have audit trail capabilities, ensuring accountability for health care providers via auditable events and tamper-resistant tracking. The ONC final rule also requires electronic health records to provide the clinical data necessary, including core data classes and elements, to promote new business models of care. This rule advances common data through the U.S. Core Data for Interoperability (USCDI). The USCDI is a standardized set of health data classes and data elements that are essential for nationwide, interoperable health information exchange. The USCDI includes “clinical notes,” allergies, and medications among other important clinical data, to help improve the flow of electronic health information and ensure that the information can be effectively understood when it is received. Because intra-team, and intra-providers communications are key aspects of safe provision of patient care, this should lead to reduction of harms and medical malpractice instances.
Another important aspect of the new rules clarifies what the patients may be charged for access to their health information, ensuring that costs of getting medical records are not an obstacle to access. The rules essentially dispose of a single district court decision from January 2020 (in Ciox Health, LLC v. Azar) that put in question whether patients’ representatives, such as attorneys investigating potential malpractice, could be charged higher amounts for obtaining their clients’ records. This “Final Rule” on page 955, is legislatively reversing that federal district court decision limiting production costs of production of EHR records to requests by the patients, whether the requests come directly from or to the patient of patient representatives. Combined with last year’s Massachusetts Appeals Court decisions in Montanez v. 178 Lowell Street Operating Company LLC, 95 Mass. App. Ct. 699 (2019) and Pennington v. Steward Health Care Systems, LLC & others, 96 Mass. App. Ct. 1103 (2019), if providers delay or overcharge patients for access to their records, their rights can be enforced under chapter 93A and they wrongdoers will have to pay for their violations, including paying for all costs and legal fees incurred.
For full text of the Montanez v. 178 Lowell Street Operating Company LLC, 95 Mass. App. Ct. 699 (2019) decision, please visit: http://masscases.com/cases/app/95/95massappct699.html
For full text of the Pennington v. Steward Health Care Systems, LLC & others, 96 Mass. App. Ct. 1103 (2019), decision, please visit: https://www.leagle.com/decision/inmaco20190923180
For HHS official press release, please visit: https://www.hhs.gov/about/news/2020/03/09/hhs-finalizes-historic-rules-to-provide-patients-more-control-of-their-health-data.html
For more information on the ONC final rule, please visit: https://healthit.gov/curesrule.
For more information on the CMS final rule, please visit: https://www.cms.gov/newsroom/fact-sheets/interoperability-and-patient-access-fact-sheet.
To view the CMS final rule, please visit: https://www.cms.gov/Regulations-and-Guidance/Guidance/Interoperability/index. To view the ONC final rule, please visit: https://healthit.gov/curesrule