Reporting standards for claims about bioelectronic and energy-storage devices: denominators, scope statements, and the arithmetic of a zero
Technical and clinical claims about devices are routinely published in a form that cannot be checked. A cycle count arrives without a temperature, a rate or an end-of-life criterion. A safety statement arrives without a denominator. A percentage arrives without any indication of whether it was measured, simulated or computed from an assumption. A figure is quoted from a third-party test report without stating what the report tested, or whether a control arm existed. In each case the number may be correct and the reader still has no way to establish that, which converts a factual statement into an assertion of trust. This paper proposes four reporting disciplines that make such claims checkable: state the denominator and the observation window; state the measurement scope, including what was not measured and whether a comparator ran; distinguish arithmetic from measurement, labelling each figure as measured, derived, drawn from literature or proposed; and, where a count of adverse events is zero, report the upper confidence bound implied by the sample size rather than an absolute absence. The disciplines are worked through six examples drawn from the author's own bioelectronic and hybrid energy-storage work, including a case in which applying the rule of three shows that his own observational safety statement supports no numerical bound at all, because its denominator was never recorded. None of the four costs the claimant anything except the removal of unsupportable phrasing, and each converts an assertion the reader must accept into a statement the reader can test. Competing interests The author is an electronics engineer and the founder, Chief Executive Officer and Chief Technology Officer of Rohera Healthcare & Technology Pvt. Ltd., Pune, India, which develops and markets eMedica, a device combining electrical stimulation with other energy modalities and physiological sensing. He is the named inventor and holder of granted patents relating to that device, and also holds patents in unrelated energy-storage and vehicle-power fields. He therefore has a financial and intellectual interest in the field of applied bioelectricity. A granted patent establishes novelty and inventive step before a patent office; it is not evidence of efficacy, and nothing in this record should be read as such. This paper proposes reporting standards for claims about bioelectronic and energy-storage devices — that is, standards that bear directly on the author's own products and on claims he and his companies have made. It is published in the knowledge that it invites the reader to hold the author to it. Funding This work received no external, grant or institutional funding. It was funded by the author, through his companies. Self-funding is declared here as a competing interest rather than as the absence of one: no external sponsor, grant reviewer or independent body reviewed, constrained or verified this work at any stage. Use of AI-assisted tools A large language model (Claude, Anthropic) was used for literature retrieval, verification of citation metadata against indexed records, and drafting assistance. The author directed the work, reviewed and edited all content, and takes full responsibility for it. No AI tool is an author. This declarations block was added on 18 September 2026 as a metadata edit, so that it is visible on the record page and not only inside the deposited file. The deposited file and the substance of the record are unchanged, and the DOI is unchanged.
Authors
- Hemant K. Rohera (ORCID: https://orcid.org/0009-0005-3275-1743)
Publication Details
- Journal
- Zenodo (CERN European Organization for Nuclear Research)
- Published
- 2026-09-18
- DOI
- https://doi.org/10.5281/zenodo.22828647
- Primary Topic
- Quality and Safety in Healthcare
- Type
- preprint