In the practice and regulations of healthcare, scholars examine the meaning of using the data reported by the patient.
More than 26 % of drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2022 With a label Based on the results reported directly by the patient. Despite the trend use The results of US health care are not traditional in clinical medical treatment reported by patients. Evaluated By taking the voice of the patient.
recently article,, Shalona Hoffman and Andy Podogarsky of Case Western Reserve University discuss The legal and regulation meaning of relying on the report of a healthy patient is informed the practice and management of healthcare.
Hoffman and Pod Garsky Claim The privacy method must be corrected to include more protection of patient information. Even if the healthcare industry becomes more data -driven Compete The regulatory agency must pay attention to the introduction of the results of the patient’s report. Looking ahead, Hoffman and Pod Garsky I will suggest Strategy to integrate the data reported by the patient into healthcare practice, research, and regulations.
When a patient explains his health and “quality of health -related life” without an opinion from a provider, they provide what is called “”.Measurement as a result reported by the patient“(prom).
Frequent collection Through the patient’s questionnaire, PROM may notify the medical provider’s diagnosis and treatment, clinical research, drugs and device regulations, and insurance evaluation. For example, a provider Out of place Sufficient information to evaluate the patient level pain and the results of treatment. Prom, Hoffman, Pod Garsky ClaimYou can enter these data gaps.
You can make a promise advantage Provider and patient. If it is evaluated with the information reported by the provider and the administrator, Hoffman and Pod Garski NotePromes can help patients and encourage clinical decisions notified by the most important symptoms, side effects, and conversion of health.
You can also promote promotes beyond the clinical environment support Survey and monitoring functions of regulated organizations.
For example, FDA is approved as “recommend promotes in many situations”. Law Includes patient reporting data for research on various uses of FDA approval drugs. Studies that depend on Prom, Hoffman, and Podgarski explainFDA can add value as FDA develops medical devices and evaluates the effectiveness of products that have been approved in clinical care.
Also Medicea and Medicade Service Center (CMS) Approval Use in a specific setting. For example, I have a CMS Release Several initiatives, including promotes in programs designed to supplement the quality of care provided by Medicade and Medicade providers. Hoffman and Pod Garsky ReportHowever, the federal program promoted by CMS initiatives uses only Prom data with limited abilities.
Despite the early stages of using PROM, integration of promotion into healthcare practice and regulations Relevant There are considerable risks and issues.
Promes must be “highly reliable, responsive, and effective” to add value, Hoffman, and pod garlic. Compete。 They increase However, concerns about the quality, integrity, and reliability of patient reporting data. For example, patients may not end the questionnaire Respond By reflecting the desire to please the provider and want to make it unpleasant. The interpretation of the promise may be so Burden Medical providers, especially those who lack the time and training to incorporate promotion.
You can also use the promise, taking into account the amount and sensitivity of the data reported by the patient. compromise Privacy for patients.
Prom is so Covered By privacy method Portability and explanation law of health insurance in 1996 (HIPAA), it I will prevent “”Target entity“From the release of the patient data without agreeing. Hoffman and Pod Garsky NoteHowever, there are remarkable exceptions to the HIPAA regulations.
For example, the target entity Disclose Patient’s medical data without permission for the purpose of medical activities, including treatment, payment, or public health activities. Hoffman and podgurski, even if the patient information is covered by HIPAA or is changed to delete identification information explain The dataset is vulnerable to hacking and disclosure without the consent of the patient.
Considering the current gap between the privacy method and the internal security system, hoffman and podgurski question Whether there is an appropriate protection means to protect the promise.
Hoffman and Pod Garsky for promotes to deal with important data gaps I will suggest Several legal and policy strategies to minimize the risks related to the implementation of promen.
Recognize that there is a possibility that the promen is rich and very personal information. Hoffman and Pod Garsky first advocate Privacy law reform. Under current Rule,entity receive Patients’ medical information may be indirectly accessible to promotes through the patient’s consent or the exception of HIPAA.
So is Hoffman and Podgarsky to prevent unnecessary promises. Recommend Change to “”Minimum required provisionsHIPAA’s privately seal. They I will suggest Correct the rules to guarantee that the clinical team will release a PROM only when a clinical team submits a specific request to justify the need to use PROM. Implement the default rules to refrain from promoting promen, Hoffman, and Pod Garski CompeteIt will promote honest patients’ reactions, and otherwise reduce the management burden of medical providers who must organize large amounts of unnecessary data.
It predicts that the sensitivity of the data contained in the promits is predicted that when technology is developed, Hoffman and pod garlic will increase. Encourage An institution that updates the regulated entity Prom guidelines with the best practices to protect protection data.
Hoffman and Pod Garsky Recognize The current risk of promotes exceeds the benefits of obligating the use in regulatory practices. Instead, they Recommend FDA and CMS will cooperate with experts to issue guidance so that entities who choose to use promen can provide reliable data. Both FDA and CMS, Hoffman and Podgurski adviceIt is necessary to improve the monitoring and make sure that is suitable for the context used in conjunction with existing regulations.
It is uncertain whether the promise will realize their possibilities, but Hoffman and Pod Garski Offer These proposals are practical steps to deal with promoting promotions and increase the space for patient voices in healthcare management.
