FR 2020-27157

Overview

Title

Proposed Modifications to the HIPAA Privacy Rule To Support, and Remove Barriers to, Coordinated Care and Individual Engagement

Agencies

ELI5 AI

The government wants to make it easier for doctors and nurses to talk to each other and with patients while still keeping people's health information safe. They are asking people to share their thoughts about these new ideas to help improve healthcare.

Summary AI

The Department of Health and Human Services (HHS) has proposed changes to the HIPAA Privacy Rule to improve care coordination and individual engagement. These changes aim to facilitate better communication among healthcare providers, payors, and individuals, reducing unnecessary barriers and maintaining patient privacy. The proposed modifications include new definitions for terms like "electronic health record" and adjustments to individual rights for accessing their health information. HHS seeks public comments on these proposals by March 22, 2021, to ensure that the regulations support the shift to value-based healthcare.

Abstract

The United States Department of Health and Human Services (HHS or "the Department") is issuing this Notice of Proposed Rulemaking (NPRM) to modify the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). These modifications address standards that may impede the transition to value-based health care by limiting or discouraging care coordination and case management communications among individuals and covered entities (including hospitals, physicians, and other health care providers, payors, and insurers) or posing other unnecessary burdens. The proposals in this NPRM address these burdens while continuing to protect the privacy and security of individuals' protected health information.

Citation: 86 FR 6446
Document #: 2020-27157
Date:
Volume: 86
Pages: 6446-6538

AnalysisAI

The document under review is a Notice of Proposed Rulemaking (NPRM) by the United States Department of Health and Human Services (HHS) that suggests changes to the HIPAA Privacy Rule. This proposal aims to streamline care coordination among healthcare providers, insurers, and patients, contributing to the shift toward value-based healthcare while maintaining privacy and security.

General Summary

The proposed modifications to the HIPAA Privacy Rule and the Health Information Technology for Economic and Clinical Health Act (HITECH Act) are intended to eliminate existing barriers that may hinder effective communication and care management. Adjustments include new definitions such as "electronic health record" and "personal health application," enhancing patients' ability to access and manage their health information. This NPRM is part of HHS's broader initiative, known as the Regulatory Sprint to Coordinated Care, seeking public commentary by March 22, 2021.

Significant Issues and Concerns

The document employs technical medical and legal terminology that could be challenging for a general audience to understand fully. The extensive use of acronyms such as HIPAA and PHI could further complicate comprehension for readers unfamiliar with these terms. Additionally, the document's length and density might make it difficult for stakeholders to distill key information and assess the implications.

Certain aspects, such as permissible fees for accessing personal health information, lack clarity, which could lead to misinterpretation. The proposed changes to how individuals can inspect and obtain copies of their health information might benefit from practical examples. Moreover, the criteria labeled as "good faith belief" for disclosing PHI could be perceived as ambiguous, lacking a clear standard.

Another notable change is the transition from a "serious and imminent" to "serious and reasonably foreseeable" threshold for disclosing information in the interest of public safety. Without clear guidelines, this shift may result in inconsistent application.

Broad Impact on the Public

For the general public, these changes promise improved access to personal health data, potentially enhancing patient engagement and involvement in care decisions. However, there might be concerns regarding the security and privacy of this information, given the proposal to reduce identity verification requirements.

Impact on Specific Stakeholders

Patients could benefit from easier access to and control over their health data, empowering them to make informed decisions. Yet, there's a potential downside if privacy security measures are perceived as weakened.

Healthcare providers might see an increase in operational efficiency due to streamlined processes for care coordination. Still, there could be increased administrative burdens to comply with the updated privacy rules.

Insurers and payors stand to gain from more effective coordination, aligning with the move towards value-based care models. Conversely, they might face challenges adjusting to new regulations and ensuring they do not inadvertently compromise patient data privacy.

Overall, while the proposed changes are aligned with improving healthcare delivery and outcomes, they compel careful consideration of privacy implications, administrative feasibility, and clarity in communication to all affected parties.

Financial Assessment

The document features extensive discussions on financial estimates related to the proposed changes in the HIPAA Privacy Rule. These observations are crucial to understanding the potential economic impacts on covered entities and individuals.

Summary of Financial Allocations

The Department estimates that implementing the proposed changes will incur $996 million in costs within the first year. These costs are attributed to revising policies and procedures ($696 million), updating training programs ($224 million), and additional administrative expenses ($76 million). Despite these significant expenses, the Department also anticipates $880 million in first-year savings, resulting in a net cost of $116 million for that year.

Over a five-year span, the proposed changes are expected to yield overall net savings of $3.2 billion, with annual savings of $825 million projected for years two through five. This projection considers both the cost savings from eliminating acknowledgment requirements for Notices of Privacy Practices (NPP) and simplifying the minimum necessary standard.

Financial Implications for Covered Entities and Individuals

One of the document's pivotal financial discussions revolves around the cost transfer for access fees. Under the proposals, changes to the allowable fees that covered entities can charge for copies of Protected Health Information (PHI) may transfer an estimated $41.6 million in costs from entities to individuals. This shift could lead to higher fees for some individuals seeking copies of their PHI.

The document indicates a potential cost increase for supplies and postage related to providing copies of PHI that entities cannot offset through current fees, estimating this at $2,152,500 annually. However, cost savings of approximately $31 million to $67 million annually could be realized through adjustments in what entities can charge under the proposed rules.

Relation to Identified Issues

The proposed changes in financial allocations align with various issues identified in the document. For instance, the reduction in identity verification requirements may impact both the administrative burden on entities and individuals' privacy concerns. This shift might enhance access and reduce costs but also raises questions about maintaining security standards for PHI.

Additionally, the adjustment in permissible fees addresses concerns about the clarity and fairness of costs imposed on individuals. Yet, this introduces a transfer of financial burden, which should be examined for broader implications on individuals’ ability to access their health information.

The estimated cost savings align with the department's objective to reduce unnecessary burdens. However, stakeholders might require further elaboration on how these cost savings translate into tangible benefits without compromising the intended protections of the HIPAA Privacy Rule. This could include clearer guidelines or examples to illustrate how the changes would effectively balance cost reduction with privacy preservation.

In essence, the financial references in the document provide a comprehensive view of the potential economic impact and the shift in costs between entities and individuals, emphasizing the need for careful consideration of implementation to ensure alignment with privacy protection goals.

Issues

  • • The document uses complex medical and legal terminology which may not be accessible to a general audience.

  • • There is extensive use of acronyms (e.g., HIPAA, PHI), which might be unclear for readers not familiar with these terms.

  • • The document is lengthy and dense, which may make it challenging for stakeholders to identify key points and implications.

  • • The details about permissible fees for accessing PHI and ePHI might require more clarity to avoid misinterpretation.

  • • The changes proposed regarding the individual’s right to inspect and obtain copies of PHI might benefit from clearer examples or scenarios to illustrate practical application.

  • • The use of the term 'good faith belief' in determining the disclosure of PHI might be seen as ambiguous without further clarification on what constitutes good faith.

  • • The shift from 'serious and imminent' to 'serious and reasonably foreseeable' regarding threats to health or safety might require clearer guidelines to ensure consistent application.

  • • The discussion on eliminating the requirement for written acknowledgment of receipt of a provider's NPP could include more detail on how this impacts patients' understanding of their privacy rights.

  • • Potential concerns could be raised regarding the impact of reduced identity verification burden on ensuring security and privacy of PHI.

  • • Specific financial implications of the proposed changes (e.g., costs for covered entities and benefits for individuals) are not immediately clear and might need further elaboration.

Statistics

Size

Pages: 93
Words: 113,233
Sentences: 3,078
Entities: 7,002

Language

Nouns: 35,718
Verbs: 12,157
Adjectives: 6,859
Adverbs: 2,381
Numbers: 3,577

Complexity

Average Token Length:
5.32
Average Sentence Length:
36.79
Token Entropy:
6.20
Readability (ARI):
25.96

Reading Time

about 8 hours