Storage Standards and Solutions, Data Storage, Sharing, and Structuring in Digital Health: A Brazilian Case Study

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The paper explores key international health IT standards and blockchain-based technological approaches to address interoperability and cybersecurity challenges in implementing EHRs.

The paper carries out a detailed analysis of the standards, description and main commercial applications based on blockchain technology, with a focus on a Brazilian case study.

A section dedicated to discussion, trends and research challenges provides useful elements for the reader to identify the most appropriate ways to apply the standards and technologies currently available.

However, the paper would benefit from the following improvements:

- the boundary between the description of general standards/approaches and the choices made for the Brazilian case study is not always clear. For example: i) in the section dedicated to terminologies, international standards are described (SNOMED CT, LOINC, ICD), but also terminologies used in Brazil (TUSS); ii) in Section 4, both commercial solutions made available on the market and the solution under development in Brazil are described. It would be useful to make the discrimination of the general solutions with those adopted in the case study clearer;

- Figure 5 shows an example of a message based on HL7 v2 using the vertical bar "|": it would be useful to write that more recent versions of HL7 v2 are based on XML;

- there is a brief mention of organizations such as IHE (which is neither a research project nor a government action) in Section 5, but a more detailed description of it in Section 1 would be useful, given the diffusion of some of its profiles such as a XDS based on existing standards.

Author Response

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Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

The paper analyses health data challenges associated with the existence of diverse data formats and fragmented records across multiple data silos, and privacy associated with health systems interoperability.

A comprehensive examination of the main standards employed for storing and sharing EMRs (such as HL7, DICOM, FHIR and openEHR) is performed. Specific use domains as storage, sharing, structure, and terminologies are also considered,

The paper discusses the advantages and specific technical challenges (as scalability, usability, immutability, privacy, security, etc.) of blockchain technology for data sharing and access policy, as a potential solution for standardizing and facilitating interoperation between health systems.

Special focus is put on a Brazilian case study used to explores the significance of EMR standards, security challenges, and blockchain-based approaches to promote interoperability and secure data sharing in the healthcare industry.

An interesting Discussion Chapter related to the fact that blockchain technology is considered complementary to legacy systems and is not replacing them is provided by the authors. Strengths, challenges as well as limitations are identified.

The subject is interesting and relevant. The state of the art in the field is based on appropriate and up-to-date references. The paper has a clear and logical flow. The topics are analysed with clarity by the authors.

I have some comments/suggestions in order to improve the quality of this paper:

1.      I think that the authors should more clearly specify which are the main objectives of their research;

2.      The originality/novelty of the approach should be emphasized at the end of the Introduction. In particular, it would be useful if the authors explain what this paper adds to the subject area compared with other published materials on the same topic;

3.      Based on the evidence and arguments presented into the paper, the authors should underline that the conclusions are consistent with and do address the main objectives of their research;

4.      Figure 1 should be named “The structure of the paper“. The description of the content of Figure 1 (“The solid arrows indicate the recommended sequence of sections for readers already familiar with basic blockchain technology concepts, while the dashed arrows point to a detour through Section 2, which provides an introduction to the fundamentals of blockchain technology”) should be included into a separate paragraph.

5.      Similar comments for Figures 3, 4, 5, 7, 8, 9, 10, 11, 13 and Table 2;

6.      There are some problems in using abbreviations:

·         There are repeated definitions of the same abbreviation (e.g. for EMR, CDA, ANS, AMB, COPISS, FSN, WHO, CDS, CSF, ABAC, LGPD, etc). Please define abbreviations only once;

·         I Think that it would be good to add a table with abbreviations at the end of the paper;

7.      Table 4 is cited in line 1067 and included after line 1151 that is 2 pages bellow. As stated into Instructions for Authors for Information Journal, “All Figures, Schemes and Tables should be inserted into the main text close to their first citation“ (https://www.mdpi.com/journal/information/instructions). Please, insert the figure closer to its citation;

For these reasons, I would recommend a major revision of the manuscript.

I hope my feedback is useful to the authors in improving their paper and wish them all the best in pursuing this important area of research.

Author Response

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Author Response File: Author Response.pdf

Reviewer 3 Report

Comments and Suggestions for Authors

The paper begins by emphasizing the critical need for agile health services capable of reliable and secure information exchanges, particularly in the context of the COVID-19 pandemic. It identifies the challenge of sharing Electronic Medical Records (EMRs) across diverse data formats and fragmented records. The introduction further elaborates on these challenges, citing medical errors due to poorly coordinated care as a significant issue. The paper sets the stage for discussing blockchain technology as a solution for these challenges.

Strengths:

1. Relevance and Timeliness: The paper is highly relevant in the current healthcare context, addressing the pressing issue of EMR interoperability and data security.
2. Comprehensive Coverage: It thoroughly examines standards for storing and sharing EMRs, delving into different aspects like storage, sharing, structure, and terminologies.
3. In-depth Analysis of Blockchain Technology: The paper provides a detailed discussion on how blockchain can enhance EMR management by ensuring data integrity, decentralization, transparency, and security.
4. Case Study Approach: Focusing on a Brazilian case study adds practicality to the theoretical aspects, offering real-world insights.
5. Identification of Systemic Issues: The paper successfully identifies systemic issues in healthcare data sharing and the potential for medical errors, highlighting the need for improvement.

Weaknesses:

1. Technical Complexity: The paper might be overly technical for readers not well-versed in blockchain technology, which could limit its accessibility.
2. Limited Scope of Case Study: While the Brazilian case study provides practical insights, it might not fully represent the challenges or solutions applicable to other regions with different healthcare infrastructures and regulations.
3. Potential Bias Towards Blockchain: The paper seems to strongly advocate for blockchain without equally discussing alternative solutions or the limitations and challenges of implementing blockchain in healthcare.
4. Lack of Empirical Data: The paper would benefit from more empirical data or case studies to support its claims, particularly regarding the effectiveness of blockchain in healthcare settings.
5. Implementation Challenges: While the paper discusses the potential of blockchain, it may not adequately address the real-world challenges of implementing such technology in existing healthcare systems, including cost, integration with current systems, and user training.

Conclusion: The paper makes a significant contribution to the discussion on improving EMR interoperability and security in healthcare. Its focus on blockchain technology as a potential solution is both innovative and pertinent. However, the paper could be strengthened by addressing its technical complexity, expanding the scope of its case studies, and providing a more balanced view of the challenges and alternatives to blockchain technology in healthcare systems.

Comments on the Quality of English Language

NA

Author Response

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Author Response File: Author Response.pdf

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

I would like to thank the authors for taking into consideration my comments and suggestions and revising their manuscript in order to improve the clarity, transparency and readability of their paper. The provided explanations clearly described how they have addressed each of my comments and what changes have been made.

I consider that the authors took into consideration all my concerns /recommendations.

I have only one minor suggestion: I think that it would be better to have only the title of the figures 1, 3, 4, 5, 7, 8, 9, 10, 11, 13 and Table 2 written after the figure/table number. Related explanations should be included in a separate paragraph in the text of the paper.

After these minor changes are made, I consider that the paper can be published.

Author Response

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Author Response File: Author Response.pdf