A Portable, Patient-Possessed Health Record: Architecture for Care Coordination as an Alternative to Centralized Data Aggregation

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

This manuscript addresses a subject of considerable interest for the healthcare community by proposing an alternative, patient-controlled medication-record architecture. As digital technology becomes more accessible and more integrated in day-to-day activity, its benefits in health information management should be explored.

 The author presents an interesting perspective and proposal. To enhance its relevance to a international audience, please consider the following suggestions.

Please add an international comparison section. Real-world implementations of various systems would create a global context against which to compare advantages and limitations.

It would be beneficial for the reader to have a dedicated Ethics section, using biomedical ethics principles.

A SWOT analysis would help identify key points that summarize the proposed concept, and it can constitute a take-away for the reader. It could be presented as a figure or a table.

I would suggest a more balanced comparison with the centralized systems, also the tone of the presentation would benefit from a more scholarly neutral approach.

The feasibility and implementation challenges should be expanded to include specific solutions and time frames for addressing card loss, replacement procedure, updates following medication changes.

Please propose specific criteria for evaluating the performance after implementation regarding clinical aspects, patient-centered outcomes and economic impact.

Author Response

Response to Reviewer Comments

Manuscript: “A Portable, Patient-Possessed Health Record: Architecture for Care Coordination as an Alternative to Centralized Data Aggregation” (amended title)

I thank the Editor and the three reviewers for their careful and constructive reading of the manuscript. The reviews were generous, and the suggestions have materially improved the paper. Below, I respond to each comment in turn. For every point, I indicate the specific change made and where it appears, and I note where a suggestion extends beyond the scope of a conceptual, opinion-format article. All changes are marked in the manuscript using tracked changes, so the editors can review each revision individually.

Two cross-cutting points

1. The “Guardian Card” is a concept, not a product. Two reviewers understandably read the manuscript as describing a marketed product. It is not to my knowledge. “Guardian Card” is simply a label I coined to name the conceptual architecture the paper proposes. No commercial product exists under this or any related name, and I have no financial interest in any such product. I have made this explicit at first mention in the Introduction, in the Abstract (“a conceptual architecture, not a commercial product”), and in the Conflicts of Interest statement, and I have reframed the design sections so the concept is primary and the card is presented as one instantiation of it. This directly addresses Reviewer 3’s second observation and removes the “single-product endorsement” reading.
2. Tone and balance. Reviewers 1 and 3 asked for a more neutral scholarly register and a fairer treatment of centralized systems. I have neutralized the most charged phrasing throughout (examples below), added a new subsection that states plainly what centralized architectures achieve, and added an ethical analysis that frames the comparison as one between two imperfect designs rather than between a flawed status quo and a costless alternative.

Note on scope

None of the comments fall wholly outside the paper’s scope, and I have acted on all of them. Two suggestions extend beyond what a conceptual article can deliver, and I have addressed them at the appropriate level while flagging the remainder as future empirical work. First, a comprehensive comparison of real-world national implementations (Reviewer 1, point 1) is a systematic-review undertaking; for an opinion piece grounded in United States constitutional law I have added focused international context rather than an exhaustive systems comparison, and I say so in the text with a new table (Table 1) and representative international examples. Second, executing a performance evaluation across clinical, patient-centered, and economic domains (Reviewer 1, point 6) requires primary empirical study; I therefore propose concrete evaluation criteria and identify the evaluation itself as future work, consistent with the manuscript’s and Reviewer 2’s framing.

I am grateful for Reviewer 1’s endorsement of the topic and for seven specific suggestions to strengthen the paper’s relevance to an international readership. Each is addressed below.

Comment 1. Please add an international comparison section. Real-world implementations of various systems would create a global context against which to compare advantages and limitations.

Response. Added as new Section 2.7, “International Context and the Recognized Benefits of Centralized Architectures.” The subsection situates the proposal against national systems that combine centralization with strong patient-facing governance—Estonia’s patient-inspectable access log, the European Union’s explicit-consent and purpose-limitation regime under the GDPR (new reference 53), and the emerging European Health Data Space. As noted under Scope, a full comparative evaluation of national implementations is beyond a conceptual article; the subsection, therefore, provides focused international context and states this limitation explicitly. In addition, Table 1 was added to provide representative international examples.

Comment 2. It would be beneficial for the reader to have a dedicated Ethics section, using biomedical ethics principles.

Response. Added as new Section 9, “Ethical Analysis,” organized around the four principles of biomedical ethics—respect for autonomy (9.1), beneficence and non-maleficence (9.2), and justice (9.3)—citing Beauchamp and Childress (new reference 54). The section states the design’s ethical aims and, importantly, surfaces its tensions: that control can be coerced (limiting autonomy), that the design introduces its own potential harms requiring mitigation (non-maleficence), and that an equity-blind rollout could reproduce the disparities it seeks to remedy (justice).

Comment 3. A SWOT analysis would help identify key points that summarize the proposed concept, and it can constitute a take-away for the reader. It could be presented as a figure or a table.

Response. Added as Table 2, a SWOT analysis of the patient-controlled architecture, placed at the end of Section 6 as a compact reader take-away. Each quadrant (strengths, weaknesses, opportunities, threats) is populated from the paper’s analysis, including the design’s genuine weaknesses and external threats.

Comment 4. I would suggest a more balanced comparison with the centralized systems, also the tone of the presentation would benefit from a more scholarly neutral approach.

Response. Addressed in two ways. Balance: new Section 2.7 acknowledges the substantial, well-documented benefits of centralized architectures—pharmacovigilance and adverse-event signal detection, population-health management, public health emergency response, linkage-dependent “big data” research, and reduction of duplicative testing—and Section 9.2 frames the choice as one between two imperfect designs. Tone: the most charged phrasing has been neutralized via tracked changes—for example, the title (“Without Centralized Surveillance” → “as an Alternative to Centralized Data Aggregation”), the Introduction’s “the most comprehensive infrastructure for population-scale biological surveillance in the domestic history of American governance” → a measured formulation, and the break-glass passage’s “the surveillance state reenters by exception” → “centralized access could reenter by exception.” I have done my best to “curb my enthusiasm” for a more liberty-centered, patient-focused system, but retained the conceptual and philosophical references that support individualism, patient autonomy, and self-efficacy. I also include a paragraph in the introduction that describes the federal government’s history regarding individual versus institutional storage and management of health data and the fact that the centralized approach was a default position, rather than deliberately decided.

Comment 5. The feasibility and implementation challenges should be expanded to include specific solutions and time frames for addressing card loss, replacement procedure, updates following medication changes.

Response. Added as new Section 5.6, “Operational Procedures: Loss, Replacement, and Update Cadence,” with concrete mechanisms and indicative time frames: on loss, key revocation within minutes of a patient report via a 24-hour issuer line, with a single-use paper credential available immediately; on replacement, a credit-card-style workflow with same-day on-site issuance or several business days by mail; and on currency, reissuance triggered by a clinically meaningful medication change, a live Tier 2 lookup in the interim, and a staleness prompt shown to scanning clinicians once a static payload exceeds a defined age (for example, 30 days).

Comment 6. Please propose specific criteria for evaluating the performance after implementation regarding clinical aspects, patient-centered outcomes and economic impact.

Response. Added as Table 3, “Proposed criteria for evaluating a deployed patient-controlled medication-record program,” with representative metrics in the three domains the reviewer names—clinical effectiveness (e.g., reconciliation-error rates, emergency-department time-to-information, adverse-drug-event rates), patient-centered outcomes (e.g., reported control over disclosure, audit-log engagement, consent-flow completion), and economic impact (e.g., issuance and key-management cost per patient, cost per averted adverse event, total cost of ownership versus centralized exchange). As noted under Scope, performing the evaluation requires primary study and is identified as future work.

Reviewer 2 Report

Comments and Suggestions for Authors

This paper presents a novel patient-centered tool for collecting and managing medical data, referred to as the Guardian Card. The author outlines the proposed solution and explains how it could be integrated into existing healthcare and health information systems.

The article argues that many of the care-coordination challenges typically addressed through centralized health information exchanges can also be resolved through an alternative approach in which the patient, rather than the institution, possesses and controls the integrative artifact. The proposed Guardian Card combines an HL7 Fast Healthcare Interoperability Resources (FHIR) clinical data payload with the SMART Health Cards verifiable credential framework and a dual-modality physical carrier incorporating both QR code and near-field communication (NFC) technologies.

A major strength of the proposal is its emphasis on patient autonomy and data confidentiality. The author highlights how the Guardian Card could provide patients with greater control over the disclosure of their medical information, including the scope and circumstances of such disclosure. At the same time, the paper acknowledges the need for carefully defined mechanisms that would permit access to critical health information without the patient's consent in emergency situations where doing so could protect the patient's life or health.

Although the author advances a patient-held architecture on both clinical and constitutional grounds, the paper appropriately recognizes that the proposed solution should be evaluated empirically and compared with established centralized health information exchange models.

While the discussion is firmly grounded in the context of the United States healthcare system and legal framework, the ideas presented may also be relevant to policymakers, healthcare professionals, and researchers working on similar initiatives in other countries.

Overall, the article is well written, thought-provoking, and interesting. In my opinion, it offers valuable insights for healthcare practitioners, health informatics specialists, policymakers, and students and educators in medical and public health disciplines.

Author Response

Response to Reviewer Comments

Manuscript: “A Portable, Patient-Possessed Health Record: Architecture for Care Coordination as an Alternative to Centralized Data Aggregation” (amended title)

I thank the Editor and the three reviewers for their careful and constructive reading of the manuscript. The reviews were generous, and the suggestions have materially improved the paper. Below, I respond to each comment in turn. For every point, I indicate the specific change made and where it appears, and I note where a suggestion extends beyond the scope of a conceptual, opinion-format article. All changes are marked in the manuscript using tracked changes attributed to the author, so the editors can review each revision individually.

Two cross-cutting points

1. The “Guardian Card” is a concept, not a product. Two reviewers understandably read the manuscript as describing a marketed product. It is not. “Guardian Card” is simply a label I coined to name the conceptual architecture the paper proposes. No commercial product exists under this or any related name, and I have no financial interest in any such product. I have made this explicit at first mention in the Introduction, in the Abstract (“a conceptual architecture, not a commercial product”), and in the Conflicts of Interest statement, and I have reframed the design sections so the concept is primary and the card is presented as one instantiation of it. This directly addresses Reviewer 3’s second observation and removes the “single-product endorsement” reading.
2. Tone and balance. Reviewers 1 and 3 asked for a more neutral scholarly register and a fairer treatment of centralized systems. I have neutralized the most charged phrasing throughout (examples below), added a new subsection that states plainly what centralized architectures achieve, and added an ethical analysis that frames the comparison as one between two imperfect designs rather than between a flawed status quo and a costless alternative.

Note on scope

None of the comments fall wholly outside the paper’s scope, and I have acted on all of them. Two suggestions extend beyond what a conceptual article can deliver, and I have addressed them at the appropriate level while flagging the remainder as future empirical work. First, a comprehensive comparison of real-world national implementations (Reviewer 1, point 1) is a systematic-review undertaking; for an opinion piece grounded in United States constitutional law I have added focused international context rather than an exhaustive systems comparison, and I say so in the text with a new table (Table 1) and representative international examples. Second, executing a performance evaluation across clinical, patient-centered, and economic domains (Reviewer 1, point 6) requires primary empirical study; I therefore propose concrete evaluation criteria and identify the evaluation itself as future work, consistent with the manuscript’s and Reviewer 2’s framing.

Comment. Reviewer 2 provided a detailed and supportive summary of the proposal, highlighting its emphasis on patient autonomy and data confidentiality and its appropriate acknowledgment of both emergency-access needs and the need for empirical evaluation against centralized models. No specific revisions were requested.

Response. I thank Reviewer 2 for the careful reading and for accurately characterizing the architecture’s aims. No changes were requested, and none specific to this review were required. The general revisions described above—neutral tone, a balanced treatment of centralized systems, the new ethical analysis, and the clarification that the “Guardian Card” names a concept rather than a product—reinforce the strengths the reviewer identified.

Reviewer 3 Report

Comments and Suggestions for Authors

Thank you for the opportunity to review this interesting paper.

It is clearly stated that this is an opinion piece - the author's own opinions expressed to stimulate wider discussion, so it is to a very large extent up to the author what is included.  The information that is expressed is very clearly expressed and supported by appropriate referencing.  The arguments are developed in logical sections and make interesting reading.

As an outsider, reflecting on Prof Parrish's opinions as expressed, I offer two observations that I believe could give some readers some concern (although I note that in writing such a piece, leaving some concerns in the readers stimulates response and further discussion).  

Firstly the arguments against centralized system are very well expressed, although many of the issues raised around who has access and under what circumstances can be resolved by public consensus (although preferably at a federal level rather than each of 50 individual states).  However I feel the manuscript is weak on the side of the advantages of centralized databases and some of the progress arising out of 'big data' analyses. A short paragraph on this would make the paper (to me) feel more balanced.  

Secondly, I note the author clearly states no conflict of interest, but around half of the paper reads, to me, as a ringing endorsement of one single product.  It may be that at present, the Guardian Card referred to is unique in the market, but in terms of a scientific opinion piece, to me, and I believe to a wider scientific audience, it would read much more comfortably if this section discussed the concepts on which the card is based and then presents the card as one extant example of the concepts in action.

The opinions expressed are useful, eloquently expressed and thought provoking. I would welcome their publication.

Author Response

Response to Reviewer Comments

Manuscript: “A Portable, Patient-Possessed Health Record: Architecture for Care Coordination as an Alternative to Centralized Data Aggregation” (amended title)

I thank the Editor and the three reviewers for their careful and constructive reading of the manuscript. The reviews were generous, and the suggestions have materially improved the paper. Below,I respond to each comment in turn. For every point, I indicate the specific change made and where it appears, and I note where a suggestion extends beyond the scope of a conceptual, opinion-format article. All changes are marked in the manuscript using tracked changes attributed to the author, so the editors can review each revision individually.

Two cross-cutting points

1. The “Guardian Card” is a concept, not a product. Two reviewers understandably read the manuscript as describing a marketed product. It is not. “Guardian Card” is simply a label I coined to name the conceptual architecture the paper proposes. No commercial product exists under this or any related name, and I have no financial interest in any such product. I have made this explicit at first mention in the Introduction, in the Abstract (“a conceptual architecture, not a commercial product”), and in the Conflicts of Interest statement, and I have reframed the design sections so the concept is primary and the card is presented as one instantiation of it. This directly addresses Reviewer 3’s second observation and removes the “single-product endorsement” reading.
2. Tone and balance. Reviewers 1 and 3 asked for a more neutral scholarly register and a fairer treatment of centralized systems. I have neutralized the most charged phrasing throughout (examples below), added a new subsection that states plainly what centralized architectures achieve, and added an ethical analysis that frames the comparison as one between two imperfect designs rather than between a flawed status quo and a costless alternative.

Note on scope

None of the comments fall wholly outside the paper’s scope, and I have acted on all of them. Two suggestions extend beyond what a conceptual article can deliver, and I have addressed them at the appropriate level while flagging the remainder as future empirical work. First, a comprehensive comparison of real-world national implementations (Reviewer 1, point 1) is a systematic-review undertaking; for an opinion piece grounded in United States constitutional law I have added focused international context rather than an exhaustive systems comparison, and I say so in the text with a new table (Table 1) and representative international examples. Second, executing a performance evaluation across clinical, patient-centered, and economic domains (Reviewer 1, point 6) requires primary empirical study; I therefore propose concrete evaluation criteria and identify the evaluation itself as future work, consistent with the manuscript’s and Reviewer 2’s framing.

I thank Reviewer 3 for the encouraging assessment and for two observations that have improved the paper’s balance and framing.

Comment 1. The arguments against centralized systems are well expressed, but the manuscript is weak on the advantages of centralized databases and the progress arising out of ‘big data’ analyses. A short paragraph on this would make the paper feel more balanced. (Many access concerns could also be resolved by public consensus, preferably at the federal rather than the state level.)

Response. Addressed in new Section 2.7, which states clearly what centralized architectures achieve, including linkage-dependent and “big data” research, pharmacovigilance, and population-health and public health functions, and which frames the paper’s claim as being about governance and architecture rather than a denial of benefit. Section 9.2 reinforces that the relevant comparison is between two imperfect designs. On the federal-versus-state point, I agree; the architectural argument advanced here is compatible with—and would be strengthened by—federal-level consensus on access standards, and I have kept the paper’s focus on the architectural layer that such consensus would still need to govern.

Comment 2. Around half of the paper reads as a ringing endorsement of one single product. It would read more comfortably if this section discussed the concepts on which the card is based and then presented the card as one extant example of the concepts in action.

Response. This is well taken, and it reflects a misreading I have now corrected at the source. The “Guardian Card” is not a product but a coined label for the conceptual architecture. I have now stated this explicitly in the Introduction, Abstract, and Conflicts of Interest, and I have reframed the design sections so the concept is primary—Section 6 now introduces “one concrete instantiation of the patient-controlled architecture, here labeled the Guardian Card,” rather than “a single artifact, the Guardian Card,” and parallel language appears in the Abstract and Introduction. I would note one difference from the reviewer’s framing: because no product of this name exists, the card is presented not as an “extant example” but as an illustrative design that makes the concept concrete. The substance of the suggestion—lead with the concept, treat the card as one realization of it—has been adopted throughout.

Round 2

Reviewer 1 Report

Comments and Suggestions for Authors

I appreciate the direct and concise manner in which the author addressed all of my comments. 

Reviewer 2 Report

Comments and Suggestions for Authors I rated the work highly in its original version, and now with additional updates, I maintain my recommendation for its publication.      

Reviewer 3 Report

Comments and Suggestions for Authors

All my concerns have been addressed. I welcome publication.