[Cardiology telemedicine solutions - opinion of the experts of the Committee of Informatics and Telemedicine of Polish Society of Cardiology, Section of Non-invasive Electrocardiology and Telemedicine of Polish Society of Cardiology and Clinical Sciences C]. / Cardiology telemedicine solutions ­ opinion of the Committee of Informatics and Telemedicine of Polish Society of Cardiology (PSC), Section of Non-invasive Electrocardiology and Telemedicine of PSC and Clinical Sciences Committee of the Polish Academy of.

For several years, we have observed the dynamic development of technologies that allow patients to access medical care from the comfort of their homes, without direct contact with the doctor. Innovative solutions based on telemedicine improve care coordination and communication among clinicians, patients, and their families, as well as increases patients' security and gives them greater independence, thus eliminating health care inequalities. The rapidly growth of telemedicine and the adoption of new technologies in clinical practice is also observed in Poland. Crucial moment for the telemedicine facilitation process in our country was Baltic Declaration approved by Minister of Health in 2015, as well as the Medical Profession Amendment Act and remote medical care admission. Since then, as part of the work of the Information Technology and Telemedicine Committee of the Polish Cardiac Society and the Telemedical Working Group, important steps have been taken to implement a telemedicine solutions in the Polish healthcare system, resulting in improved quality and efficiency of this system. The presented document reflects the above actions and encompasses following issues: available telemedicine solutions in the world, analysis of their effectiveness based on clinical trials, funding opportunities, legal status and development prospects telecardiology in Poland.

Legal grounds for 'extending the scope or type of procedure'.

INTRODUCTION: The development of patient rights and increasing number of lawsuits based on medical malpractice make medical doctors constantly improve knowledge regarding the acceptability of changing the scope of operation. This is particularly important when patients have expressed their refusal to changing the scope and type of procedure (ESTP) or no informed consent (IC) has been obtained from the patient prior to the procedure. MATERIAL AND METHODS: The method of study comprised content analysis of existing legislation. The current jurisprudence and doctrine were confronted with existing regulations. An algorithm of correct formal procedures was elaborated. RESULTS: The doctor has right to realize ESTP when the patient has not given the consent to it or the refusal expressed by him was not fully conscious. Healthcare providers are absolutely prohibited from realizing ESTP when patient objected to any changes being thoroughly informed by the physician prior to the operation. When patient refuses possible ESTP, the doctor has the right to withdraw from performing surgery but should inform the patient about other places, where a similar procedure can be provided.

["Baltic Declaration"--telemedicine and mHealth as support for clinical processes in cardiology. The opinion of the Committee of Informatics and Telemedicine of the Polish Society of Cardiology and Telemedicine Clinical Sciences Committee of the PAS]. / "Deklaracja Baltycka"--telemedycyna i mHealth jako wsparcie procesów klinicznych w kardiologii. Opinia Komisji Informatyki i Telemedycyny Polskiego Towarzystwa Kardiologicznego oraz Zespolu ds. Telemedycyny Komitetu Nauk Klinicznych PAN.

For several decades we have observed the development of data transmission technology on an unprecedented scale. With the development of such technology there has also appeared concepts on the use of these solutions in health care systems. Over the last decade telemedicine has been joined by the concept of mHealth, which is based on mobile devices mainly to monitor selected biomedical parameters. On 10 October 2014, during the conference Baltic Electrocardiology Autumn - Telemedicine and Arrhythmia (BEATA), a debate was held with the participation of physicians, politicians, businessmen, and representatives of the Government (Ministry of Health, National Health Fund, Social Insurance Institution) concerning the use of telecardiology services in daily practice. During the meeting issues were discussed such as: telemedicine solutions available throughout the world, analysis of their effectiveness based on clinical trials, funding opportunities, their legal status, and the development perspectives of telecardiology in Poland. The result of the meeting was a document called the "Baltic Declaration". The declaration is a call for proven and profitable technologies to be introduced into clinical practice. The declaration also indicates that the variety of available technological solutions are merely tools, and the utility of such tools stems not only from their modernity, but also primarily from matching their functionality to the features of the health interventions that are to be improved.

Should a doctor stop rendering medical services? Part II - Analysis of medico-legal conduct in cases of uncertainties regarding informed consent in minors. The Polish perspective.

INTRODUCTION: The doctor's decision whether to save the life of a minor who has attempted to commit suicide depends on the decision of the person who, under legal regulations, is responsible for the minor. In everyday medical practice doctors are often placed in difficult situations and often cannot make any decision. Such doubts arise when it is impossible to contact the person(s) responsible for the minor. The doctor encounters similar issues when the parents of a minor under 16 years of age express different opinions on the recommended procedures, and are against the doctor's decision and do not want their child to be hospitalized. MATERIALS AND METHODS: The current legislation and doctrine was analyzed and an attempt was made to determine the way of conduct with regard to suicidal minors, and algorithmize the way of conduct towards such suicidal minors. The conduct was discussed on the two examples, based on real clinical cases. RESULTS: With regard to minors in a clinical state demanding urgent procedures, who have of the decision made by the guardian, and regardless of the fact there is no contact with the guardian. If the status is stable, the physician's modus operandi depends on various accompanying circumstances. However, he is still obliged to provide medical help. DISCUSSION: A practical algorithm is presented and all the possible legal variations discussed and clarified.

Knowledge of medical law amongst doctors of internal diseases.

OBJECTIVES: In Poland, 95% of medical personnel had not received legal education before they completed their studies. Having been given these facts, we have started questioning legal awareness of people providing medical services. AIM OF THE STUDY: The study aimed at evaluating the knowledge of allergists and pulmonologists. MATERIAL AND METHODS: The group consisting of 328 allergists and/or pulmonologist completed the questionnaire. RESULTS: The participants possess the best knowledge in providing information to patients about their health status (CV1). Sixty nine % of responders replied correctly, and the difference was significant (p < 0.001) in comparison with next aspect referring to the principles of providing medical services following guidelines created by think-tanks and also possibilities to take autonomous decisions by physicians (CV2). The correct answers in relation to CV2 were given by 57% of responders. The third compared aspect was physicians' awareness of patients' right to giving a consent or refusal before undertaking the medical procedure CV3. Only 55% of physicians gave correct answers and the difference was significant compared to CV1 (p < 0.001) as well as CV2 (p < 0.05). Younger doctors showed to have better knowledge than their older colleagues (p < 0.05). Working in urban workplaces proved to be more associated with better knowledge than in rural ones (p < 0.05). DISCUSSION: Insufficient knowledge results in a low quality of provided services and puts the doctors at risk of being liable. The rates indicate that doctors are not aware of the fact that only legal regulations are binding, while standards not published by the Minister of Health are not legally valid. Half of the respondents have the wrong belief that the opinions expressed by experts make the doctor feel exempt from liability. Probably there are specialities, like occupational medicine which are specially linked with awareness of valid legal rules.

Should a doctor stop rendering medical services? Principles of conduct towards patients attempting to commit suicide. Part 1 -- the Polish perspective.

INTRODUCTION: According to the general idea a doctor can start the medical management process in an adult and not legally incapacitated patient after the patient has given consent to initiate such a process. The patient's refusal makes rendering medical services impossible, irrespective of their scope and kind. It should be emphasized that such a refusal is respected if it is expressed fully, clearly and consciously. Cases in which such a refusal is expressed by an intoxicated suicidal patient, remaining under the influence of narcotics, drugs or medicaments which characterize with a similar activity should be particularly analysed. Although such a person is able to verbally declare his objection, his ability to process the information given by the doctor before initiating medical procedures is limited, or even non-existant. The refusal therefore cannot be regarded as reliable, which results in rendering medical services to the patient. MATERIALS AND METHODS: An analysis was made of Acts of Law and the opinions of the judiciar by comparing and excluding contradictory and incoherent elements. RESULTS: Despite the lack of clear regulations of a patient rejecting procedures aimed at saving the patient's life, or the prevention of serious health impairment or sustaining injury, it should be assumed that the objection expressed by the patient who does not demonstrate the ability to process the information provided by the doctor is not reliable, and the doctor is therefore still obliged to render medical services. External factors, such as consumption of alcohol, narcotics and drugs, which characterize with a similar activity impair perception and make the taking of a conscious decision impossible. Not providing medical help and introducing direct compulsion would mean neglecting provision of due diligence in the process of treatment and, as a consequence, placing the patient's health at risk, and suffering from negative implications for the patient's life and/or health in the future. CONCLUSIONS: Current provisions should directly regulate the negligence of respecting a refusal expressed 'unconsciously' by a patient who remains under the influence of alcohol, narcotics, drugs or medicaments which characterize with a similar activity. Moreover, apart from legal provisions, the law providers should consider introducing a direct compulsion in patients who are unable to make a conscious decision in the treatment process.

Cell phone ringtone, but not landline phone ringtone, affects complex reaction time.

INTRODUCTION: Legislation systems of most countries prohibited using the handheld mobile phone while driving due to the fact that it disturbs concentration and causes hand involvement. Every phone owner is accustomed to the ringtone of his phone and almost involuntarily endeavors to pick it up or check who calls. This engages one's psychomotor skills, which in our opinion contributes to the attenuation of reaction time needed for performing other crucial functions. OBJECTIVES: The aim of the study was: (1) to evaluate the influence of the sound of a ringing mobile phone on the complex reaction time (RT) score in healthy subjects (owners), and (2) to check if there are any differences in RT when a landline phone and mobile phone ring. METHODS: To assess RT we used our system and protocol of examination, previously validated. The examination conditions were standardized. All tests were performed in the same room with the same light and general acoustic conditions. The test group consisted of 23 women and 24 men, aged 19-24 years. The examination comprised 4 sessions: Training Session (TS) during which the subjects were accustomed with the application and sample stimuli, Control Session (CS) with no telephone ringing, Landline Session (LS) with landline phone ringing, Mobile Session (MS) with mobile phone ringing. RESULTS: The median RT in the study population was significantly elongated (p < 0.001) in MS. In women and in men RTs were significantly longer in MS than in CS and non-significantly longer than in LS. Reaction times in CS, LS and MS were longer in women, however the differences were not significant (p > 0.05). CONCLUSIONS: We think that the specific 'bond' between a person and their private phone can significantly disrupt their attention and thus affect the attention-demanding activities.

Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs - provision of due diligence in the treatment process.

Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on "off-label use". The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug.

The sound of a mobile phone ringing affects the complex reaction time of its owner.

INTRODUCTION: Mobile phone conversation decreases the ability to concentrate and impairs the attention necessary to perform complex activities, such as driving a car. Does the ringing sound of a mobile phone affect the driver's ability to perform complex sensory-motor activities? We compared a subject's reaction time while performing a test either with a mobile phone ringing or without. MATERIAL AND METHODS: The examination was performed on a PC-based reaction time self-constructed system Reactor. The study group consisted of 42 healthy students. The protocol included instruction, control without phone and a proper session with subject's mobile phone ringing. The terms of the study were standardised. RESULTS: There were significant differences (p < 0.001) in reaction time in control (597 ms), mobile (633 ms) and instruction session (673 ms). The differences in female subpopulation were also significant (p < 0.01). Women revealed the longest reaction time in instruction session (707 ms), were significantly quicker in mobile (657 ms, p < 0.01) and in control session (612 ms, p < 0.001). In men, the significant difference was recorded only between instruction (622 ms) and control session (573 ms, p < 0.01). The other differences were not significant (p > 0.08). Men proofed to complete significantly quicker than women in instruction (p < 0.01) and in mobile session (p < 0.05). Differences amongst the genders in control session was not significant (p > 0.05). CONCLUSIONS: The results obtained proofed the ringing of a phone exerts a significant influence on complex reaction time and quality of performed task.

Alcohol-intoxicated patients at admission room--analysis of legal aspects of rendered medical services.

Current legal regulations do not explicitly state whether the doctor should or should not ignore the patient's refusal to be provided with medical services when such refusal is given by the patients who is temporarily unable to take conscious decisions. The fact that there is no clear jurisdiction over the issue makes the relation between doctor and patient legally complicated. The doctor has no doubts whether he/she should or should not initiate the medical procedure when the patient clearly expresses the declaration of will, in which either refusal or consent is given to be provided with medical care. However, the patient remaining under the influence of alcohol, i.e. a substance which to some or great extent impairs cognitive functions, rational thinking, and the ability to evaluate incoming information. Alcohol makes the patient unable to interpret the information given by the doctor. Thus, the patient's consent or refusal to be provided with medical care is lacking in the needed elements of "informing" and "conscious declaration of will", which are considered by doctors and lawyers to be absolutely necessary to make such will valid. There are no clear, unambiguous regulations explaining how the doctor should behave in such cases. The authors of the presented study state that it is highly important to determine whether the intoxicated patient is able to understand the incoming information, evaluate it, make a conscious decision and finally, express an explicit (and therefore binding) refusal to accept recommended medical services. In the opinion of the authors, while dealing with such patients, the doctor should bear in mind the patient's right to make autonomous decisions, but that it is also the doctor's duty to provide the patient with medical services.

[The use of medicinal products "off-label use" in the pediatric population--the border risk, or reasonable diligence?]. / Stosowanie produktów leczniczych "off -label use" w populacji pediatrycznej- dzialanie na granicy ryzyka, czy dolozenie nalezytej starannosci?

Any medicinal product marketed in the country has its registration, under which are strictly defined indications and the extent to which a product can be used. It is of significance that the use of the product which is registered in the given range produces an effect similar to or identical to that effect, which is obtained after applying the product having a registration in a given indication. Relied on to justify the use of a medicinal product or medical product "off-label use" in Poland, there is also the fact that the same product has a registration in a particular indication in another EU member state or outside the Community. It is worth noting that the medicinal product may be used in therapeutic management of omitting or reducing the principles resulting from the SPC. However, this applies only to cases where the use of the medicinal product "off-label use" dictated by the necessity of saving life or health of the patient, and the previous ways and methods of treatment with the use of registered medicines have proved ineffective or insufficient to achieve the desired therapeutic effect.

[The analysis of legal basis of telediagnosis and teleconsultation in clinical practice. Are we allowed to consult our patients via phone? Part II]. / Analiza podstaw legalnosci telekonsultacji i telediagnostyki w codziennej praktyce klinicznej. Czy wolno konsultowac pacjentów przez telefon? Czesc II.

BACKGROUND: This paper is composed of two parts, the first one addresses the issue of legal grounds for teleconsultation and telemedicine in Poland, the other tries to answer the questions whether the provision of health services with use of telemedical tools does not breach medical professional secrecy or personal data protection. MATERIAL AND METHODS: The material comprised a whole set of Polish and European legal acts that could have any impact on the legal basis of telemedicine in Poland. The method applied was of interpretative nature, and the texts of above-mentioned acts were thoroughly analyzed, providing the first comprehensive study on this subject. RESULTS: The medical professional secrecy is not violated if the range of transmitted data is limited to those, which are absolutely necessary in the diagnostic and therapeutic process. This rule involves the transmission of indispensable personal and medical data, however, sharing the patient's appearance should be preceded by his/her informed consent. CONCLUSIONS: The achievements of information technology greatly contribute to the quality of diagnostic and therapeutic processes. Due to the rapid development of modern means of telemedicine we face the need to establish legal regulations, specifying the principles of distant exchange of medical data.

[The analysis of legal basis of telediagnosis and teleconsultation in clinical practice. are we allowed to consult our patients via phone? Part I]. / Analiza podstaw legalnosci telekonsultacji i telediagnostyki w codziennej praktyce klinicznej. Czy wolno konsultowac pacjentów przez telefon? Czesc I.

BACKGROUND: Telemedicine means the delivery of medical service without personal contact between the patient and physician. Although Polish legal regulations do not prohibit so called "distant medical treatment", they do not specify clear and ambiguous terms of such a service. The practitioner faces numerous doubts concerning the telediagnosis and teleconsultation. The authors discuss the problems of acceptability of telediagnosis and teleconsultation in Poland. MATERIAL AND METHODS: The material comprised a whole set of legal acts of the Polish and European origin that could have any impact on the legal basis of telemedicine in Poland. The method applied was of interpretative nature, and the texts of above-mentioned acts were thoroughly analyzed, providing the first comprehensive study on this subject. RESULTS: The results applied to practitioners of numerous medical specializations, but it should be stated that the examples studied and analyzed focused on teleconsultations in occupational medicine. The analysis revealed that current legal regulations do not specify the exact form the medical consultations should acquire. Nevertheless, it should be admitted that "distant consultation"; via the Internet, phone or other means of IT is not prohibited. The authors emphasize, however, that the distant consultations should be treated as an exception to the rule, which says that the patient should be personally consulted by the physician. CONCLUSIONS: The achievements of information technology greatly contributes to the quality of diagnostic and therapeutic processes. The existence of many unclear and ambiguous rules and opinions makes it necessary to establish legal regulations specifying the principles of distant exchange of medical data.

[The analysis the doctor-patient communication on the basis of selected clinical and demographic factors]. / Analiza komunikacji lekarz-chory w swietle wybranych cech demograficznych i klinicznych.

BACKGROUND: The aim of the study was to analyze the doctor-patient communication on the basis of selected clinical and demographic factors. MATERIAL AND METHODS: The author assessed the level of patients' knowledge about their rights, availability, scope and reliability of the information conveyed by doctors, completeness and influence of information given by doctors on the validity of consent given by patients. The mentioned variables were analyzed on the basis of selected clinical and demographic factors including age, gender, education, place of residence, employment, form of employment, marital status, income, number of hospitalizations (NoH) and ICD10. The data were collected by questionnaires completed by 500 patients. RESULTS: Performing the doctor's duty of giving information to the patient and the patients' knowledge about their rights depends on their education, monthly income, place of residence, cause of hospitalization and NoH. The scope, way and perception of the conveyed information depends on patients' education, place of residence, income, cause and NoH. The influence of the information given by the doctor on the validity of consent given by the patient depends on his/her education, place of residence, income and cause and NoH. Patients have limited knowledge about their right to have a contact person established. CONCLUSIONS: The importance of obtaining adequate information before the patient gives informed consent, insufficient patients' knowledge concerning their rights and lack of similar analyses carried out in the past indicate the need to continue the relevant research in the future.

[Physicians' duty to inform about the presence of health contraindications to driving motor vehicles]. / Lekarski obowiazek informowania o istnieniu przeciwwskazan zdrowotnych do kierowania pojazdami silnikowymi.

BACKGROUND: The issue concerning the duty of physicians to inform about health problems, which could be a contraindication to driving a motor vehicle, give in practice rise to many questions. Existing regulations do not apply to this issue directly, and the available literature lacks a definite stand on this matter. Information collected by the competent authorities about health problems, which may be a contraindication to driving a motor vehicle could contribute enormously to reducing or eliminating health risks among drivers and other potential road users. MATERIAL AND METHODS: Current legislation that could in any way refer to the discussed problem were subjected to a thorough analysis and interpretation. with reference to the existing case law. RESULTS: Despite the lack of clear regulations, physicians are obliged to provide the authorized agencies with the information about health problems, which could be a contraindication to driving a motor vehicle. The transfer of this kind of information is a legitimate exemption from doctor-patient confidentiality, therefore, physicians who transfer it do not expose themselves to bearing the responsibility. In the absence of clear standards governing the scope of information that physicians should make available for relevant authorities, the information does not need, but may include a specific medical diagnosis. CONCLUSIONS: This article presents first comprehensive approach to the exchange of information between physicians and the body entitled to obtain information on medical unfit to drive motor vehicle, which is a helpful guide in daily practice.

[Efficiency of the patient's signature in examinations performed by the occupational medicine doctor]. / Skutecznosc podpisu pacjenta w badaniach wykonywanych przez lekarzy medycyny pracy.

BACKGROUND: A special relationship occurring between the doctor and the patient, besides many stipulations of the ethical nature, is controlled by numerous legal regulations. In the Polish legislative system, there are no clear and unequivocal regulations that would precisely define the diagnostic-therapeutic process. Communication, namely the exchange of information between the doctor and the patient plays a particular role in this process in which the doctor bears much greater responsibility than the patient, and thus is obliged to provide the patient with the comprehensible information presented in such a way that he or she would be able to interpret it properly. MATERIAL AND METHODS: The analysis comprised the binding legislation concerning prophylactic examination as well as drivers examination. The problem was discussed taking into account the current court judgments. RESULTS: The doctor should pay particular attention to adjusting the quality, quantity and way of conveying the information to the patient's ability to acquire and interpret it properly. This ability is associated with the patient's personal traits. There are no algorithms for the doctor-patient communication. The occupational medicine doctors are in a better situation as legislative regulations pertaining to specificity of their health services may indicate proper communication between the doctor and the patient. CONCLUSIONS: The importance of this communication has been notified in the legislative doctrine, where the idea of informative mistake has been formed. Such a mistake may have significant consequences especially for the occupational medicine doctors due to the specificity of performed functions. The article discusses legislative aspects concerning the exchange of information at the doctor-patient level, and presents some examples of judgments of Polish courts as well as numerous indications useful in everyday practice.

[Is it acceptable to carry out preventive screening in any given place?]. / Czy badania profilaktyczne mozna wykonac w dowolnym miejscu?

BACKGROUND: Employers are, among their numerous responsibilities, obliged to refer their employees or the person applying for the job to prophylactic examinations. Initial, seasonal and check-up examinations should be carried out in the primary occupational health care institution the employer is obliged to sign the contract for this kind of services, according to the binding regulations. However, due to the fact that these regulations do not contain an imperative that prophylactic examinations must be performed in the institution with which the employer is under contract, it is theoretically possible that the examinations are carried out in an outpatient department chosen by an individual who is to be examined. MATERIAL AND METHODS: The critical analysis of existing rules, judgments and writs was performed. RESULTS: In practice, such a possibility exists only in case of those who apply for the job. This results from the fact that job candidates unlike employees, are not obliged to follow the employer's official order concerning initial examinations. Employees and those employed on the basis of the civil-law contract have to obey the employer's official orders concerning the type and place of performing prophylactic examinations. The employee's disobedience in this matter may have serious consequences arising from the contravention of order and work organization rules. CONCLUSIONS: Employees employed on the basis of the civil-law contract are obliged to undergo prophylactic examinations. However, the time and the type of institution in which the examination is performed depends on the legal basis of employment. Persons applying for the job do not have to obey the employer's official orders and thus cannot be forced to perform the examination in a given time or institution. If the conditional contract is signed, the employee can start his or her work without presenting the certificate of working ability at a given post.