Given the many benefits of legal technology markets, why are law firms slow to seize the opportunities available to them? This is another example of CMS`s first procedure for setting the “event order” for an RPM program. CMS explained that after analyzing and interpreting physiological data collected remotely from a patient, the physiological data collected and transmitted can be analyzed and interpreted as described in CPT code 99091. This code covers only professional work and is evaluated to include a total of 40 minutes of medical or non-medical (NPP) work, including 5 minutes of preparatory work (file review); 30 minutes of on-the-job work (e.g., data analysis and interpretation, report based on physiological data and possible patient call) and 5 minutes of post-service work (diagram documentation). In its commentary, CMS explained that the next step in RPM is to develop a treatment plan based on the analysis and interpretation of patient data. At this point, the doctor develops a treatment plan with the patient and manages the plan until the desired goals of the treatment plan are achieved, signaling the end of the nursing episode. CPT code 99457 and its additional CPT code 99458 describe the treatment and management services associated with MPR and include the work of professionals and clinical staff. Background and purpose: Telemedicine or telemedicine services have been increasingly practised in recent years. During the COVID-19 pandemic, telemedicine has become an indispensable service to avoid contagion between healthcare professionals and patients, involving an increasing number of medical disciplines. Nevertheless, some ethical and legal issues related to the provision of these services remain unresolved and require appropriate regulation. This narrative review will provide a synthesis of key ethical and legal issues in telemedicine practice during the COVID-19 pandemic.
Materials and methods: A literature review was conducted on PubMed using the MeSH terms: telemedicine (including mHealth or health, mobile, mHealth, telehealth and eHealth), ethics, legislation/jurisprudence and COVID-19. These terms were combined into a search string to better identify relevant articles published in English from March 2019 to September 2021. Results: A total of 24 of the original 85 articles were challenged in this review. Legal and ethical issues concerned important aspects such as: informed consent (information on the risks and benefits of remote therapy) and autonomy (87%), patient privacy and confidentiality (57%), data protection and security (74%), malpractice and professional responsibility/integrity (70%), equal access (30%), the quality of care (30%), the relationship between work and the patient (22%) and the principle of charity or willingness to act in the interest of others (13%). Conclusions: Ethical and legal issues related to the practice of telemedicine or telemedicine services still require uniform and specific implementing rules to ensure equal access, quality of care, sustainable costs, professional liability, patient privacy, data protection and confidentiality. Currently, telemedicine services can only be used as complementary tools to traditional health services. Some indications for medical providers are offered. The most recent definition of telemedicine, telemedicine and related terms, published in 2020 by the U.S. Centers for Medicare & Medicaid Services (CMS), is “the exchange of medical information from one location to another through electronic communications to improve a patient`s health” [3]. Generally, companies and business partners covered by HIPAA may only use or disclose protected health information to the extent permitted or required by the HIPAA Privacy Rule (45 CFR § 164.502). Another legal way to access health information, but one that is not patient-specific, is HIPAA`s de-identification privacy policy. Anonymized health information “is considered non-individually identifiable health information” under HIPAA (45 CFR § 164.502) and can therefore be used and shared more freely, such as for research purposes.
One way to meet the HIPAA de-identification standard is to be designated by “a person with reasonable knowledge and experience of generally accepted statistical and scientific principles and methods” (45 CFR § 164.514(b)(1)). Another way to de-identify protected health information is to remove 18 specific identifiers of the person or their employers, household members, or relatives, such as names, medical record numbers, phone numbers, and email addresses. However, the latter route is only permitted if the entity concerned “has no actual knowledge that the information, alone or in combination with other information, could be used to identify a person who is the subject of the information” (45 CFR § 164.514(b)(2)). However, many fear that HIPAA is outdated for the reality of a big data world. 27 , 28 , 29 In particular, it seems to us that HIPAA does not currently have sufficient safeguards to give patients the right to access their raw data collected and stored by manufacturers, given that manufacturers of ICDs/pacemakers are likely to be business partners in most cases only with respect to PDF summaries and not with respect to raw data. Other jurisdictions, such as the EU, which we turn to next, have implemented different regulatory approaches. Thus, while in the previous example, the behaviour of the US patient with an ICD or pacemaker visiting Germany for a holiday trip continues to be monitored, behavioural monitoring is not for people in the EU, but only for patients in the US. Therefore, the processing of personal data by the processor or controller that is not established in the EU does not fall within the scope of the GDPR. The GDPR would only apply if the processor or controller is not established in the EU and aims to monitor patient behaviour in the EU. Many studies conducted before the SARS-CoV-2 outbreak on telemedicine showed high patient satisfaction. While the idea of seeing your doctor in the comfort of your home may seem like a simple and inexpensive form of medical care, the fact is that there are inherent problems associated with this type of care that could eventually have serious consequences. The RPM device must digitally (i.e.
automatically) download the patient`s physiological data (i.e. the data cannot be recorded or self-reported by the patient). As with any service provided to a Medicare recipient, the use of an RPM device to digitally capture and transmit a patient`s physiological data must be appropriate and necessary to diagnose or treat the patient`s illness or injury, or to improve the function of a malformed limb of the body. In addition, the RPM device must be used to collect and transmit reliable and valid physiological data to understand the patient`s health status in order to develop and manage a treatment plan. Remote patients may benefit or be disadvantaged by virtual care (e.g., lack of access to the Internet, smartphones, or other technologies should not prevent children from accessing their medical system) [10]. Indeed, the principle of justice includes equal access to health care and equitable distribution of technology for marginalized communities [16]. Ideally, the greatest benefit to patients should be equal and timely access to health care through telemedicine services, but this is still controversial and, in some cases, has been exacerbated during the COVID-19 pandemic (e.g. unequal access to care, prohibitive costs in a fee system, and lack of quality measures for new care modalities).
Therefore, the practice of telemedicine needs to be greatly improved, with specific rules and codes of conduct properly translated into practice in order to build a sustainable program. Although, according to the World Medical Association`s Declaration on the Ethics of Telemedicine, “face-to-face consultation between physician and patient remains the gold standard of clinical care” [4], telemedicine has become increasingly practiced in recent years. Indeed, it offers several advantages, the most important of which are the simplification of access to health facilities and the reduction of the distance between patient and doctor, especially in geographical areas where medical services are difficult to access or in the case of remote seafarers [5]. In addition, telemedicine can improve access to doctors for patients with mobility problems such as disabled patients, frail patients or elderly patients [6] and could ideally promote equal access to healthcare and timely patient participation at lower cost [1,7]. The wording of the fact sheet shows that CMS ultimately rejected its proposal to ask for 20 full minutes to interact with the patient.