CC BY
35
НАУЧНОЕ ПЕРИОДИЧЕСКОЕ ИЗДАНИЕ «CETERIS PARIBUS» №1-2/2016 ISSN 2411-717Х
МЕДИЦИНСКИЕ НАУКИ
Шалковский Алексей Геннадьевич
Директор Института Информационных Технологий НИУ ВШЭ
Михайлова Анна Георгиевна Заместитель директора Института Информационных Технологий НИУ ВШЭ
Воробьева Екатерина Евгеньевна Заместитель директора НЦ информационных систем мониторинга здоровья человека НИУ ВШЭ, email: evorobyeva@hse.ru
Антонова Ксения Александровна Стажёр-исследователь НЦ информационных систем мониторинга здоровья человека НИУ ВШЭ, email: kantonova@hse.ru
ОТКРЫТЫЕ ВОПРОСЫ ДИСТАНЦИОННОГО МОНИТОРИНГА ЗДОРОВЬЯ
Аннотация
Удаленный мониторинг пациента как одна из зарекомендованных форм телемедицины может включать в себя двустороннюю видео консультацию с медицинским учреждением, продолжающееся дистанционное измерение жизненно важных признаков или автоматизированные телефонные вызовы на основе проверок физического и психического благополучия. Подход, используемый для каждого пациента, должен быть адаптирован к потребностям пациента и согласован с планом ухода пациента. В статье рассмотрены варианты применения мобильного комплекса дистанционного мониторинга на практике и вопросы, связанные с правом доступа к персональным данным пациента.
Ключевые слова
здравоохранение, мониторинг здоровья, персональные данные пациента, информационные технологии в
медицине, мобильное здравоохранение.
Shalkovsky A. G. - Director of Institute of Information Technologies, Higher School of Economics (HSE) Mikhaylova A. G. - Deputy director of Institute of Information Technologies, HSE Vorobyeva E. E. - Deputy director of ITHMC, HSE, email: evorobyeva@hse.ru Antonova K.A. - Research assistant of ITHMC, HSE, email: kantonova@hse.ru
REMOTE MONITORING PRACTICE IN REAL WORLD
Annotation: One well-proven form of telemedicine is remote patient monitoring. Remote patient monitoring may include two-way video consultations with a health provider, ongoing remote measurement of vital signs or automated or phone-based check-ups of physical and mental well-being. The approach used for each patient should be tailored to the patient's needs and coordinated with the patient's care plan. The article describes applications of mobile remote monitoring in practice and questions related to the right to access personal data of the patient.
Keywords: healthcare, remote monitoring, personal data of the patient, information technology in Medicine, mHealth.
In order to provide innovative technology solutions and services in the eHealth domain, knowledge has to exist about the relevance of current technologies, future trends, most successful customers and market possibilities. One of them is Remote monitoring practice which can be used to deliver care to patients regardless of their physical location or ability. Research has shown that patients who receive such care are more likely to have better health outcomes and less likely to be admitted (or readmitted) to the hospital, resulting in huge cost savings. The paper is structured as follows: first, we provide the use of mobile health applications within remote patient monitoring and
USA practice in Medicaid Policy. Next part is devoted to a patient rights act. Finally, we conclude with a brief overview of the right to access to personal data. All the literature and resources used within this paper can be found in the References section.
Diagnosis and Teleconsultation
A great deal of research has been done on the use of telehealth for diagnosing disease. It has been shown that diagnosis of disease using telehealth is successful. For example, Schwabb and colleagues found that the remote interpretation and diagnosis with electrocardiogram results was just as good as interpretation in person. Additionally, telehealth has successfully been used as a tool for diagnosing acute leukemia.
Compliance and adherence problems are among the many issues that are important to achieving patient safety. After a patient leaves a provider's office or a hospital, the patient is responsible for his or her own health care at home. Patients often do not follow a treatment plan as directed by a physician or provider due to several factors, including: miscommunication or faulty understanding of the treatment plan, lack of access to facilities needed for the treatment plan, and a complex treatment regimen that the patient cannot comprehend without additional guidance. This can cause negative outcomes and creates safety issues for the patient. Therefore, inventive and efficient telehealth-based methods of caring for patients are increasingly being used to improve compliance or adherence to the prescribed regimen of care, as well as for symptom management. Telehealth is one strategy for monitoring and communicating with patients beyond the acute care setting. It has also had an impact upon health care utilization rates for acute care services (such as decreasing visits to the Emergency Department) in studies with limited sample sizes, although large randomized trials have not yet been reported.
Home Telehealth and mHealth
The use of mobile health (mHealth) applications and devices among home and community-based providers and patients is not a new phenomenon. Home health providers rely on the regular use of smart phones, tablets, and cell phones at the point of care to record and manage patient health information, and coordinate care.
In July 2011, the Food and Drug Administration (FDA) released draft guidance on the regulation of mobile health applications. The FDA identifies three types of mHealth apps that would require regulatory oversight: an application that is used as an extension of a medical device, an accessory or attachment that transforms a mobile platform into a medical device, and apps designed to support clinical decision making by analyzing, interpreting, or processing medical device data. As of June 2013, the FDA has not released final guidance on the regulation of mobile health apps. Mobile devices offer a variety of features. Although most state Medicaid plans do not consider telephone calls as a component of telehealth and will not reimburse for the service, there are no state laws which prohibit the use of smart phones, tablets or other phone-enabling mobile devices to facilitate video-conferencing or remote patient monitoring.
Generally, data collection in remote patient monitoring via measurement of vital indicators plays a triggering role and nourishes subsequent stages as illustrated in Figure 1.
Figure 1 Sequences in Remote Patient Monitoring.
Obtained data about medical situation of patient are subject to further transmission to storage silos, evaluation with cross-cutting technologies and techniques, notification to related personnel and people and intervention when required. Through the instrumentality of such a sequenced flow, monitoring systems gain the following functionality (Suh, et al., 2011):
• improving a physician's ability to monitor daily progress of a patient;
• providing a pervasive monitoring solution that easily integrates into the lifestyles of patients;
• augmenting a physician's capability in decisions making through automated data analysis of patient data;
• enacting a modular and customizable mobile monitoring platform to meet the specific needs of patients.
The Use of Telehealth and Remote Patient Monitoring in Medicaid Policies for telehealth in Medicaid vary in each state according to service coverage, payment methodology, distance requirements, eligible patient populations and health care providers, authorized technologies, and patient consent. Some states follow Medicare's restrictions, which does not recognize the home as an originating site, nor does it reimburse for remote monitoring. State policy decisions can also be driven by budget constraints, public health needs, available infrastructure or provider readiness. Medicaid plans have several options to cover remote patient monitoring, which include enacting legislation, issuing administrative regulatory changes, applying for a federal waiver (such as for home and community-based services under Social Security Act section 1915(c)) or a new "health home" option for chronic care (section 1945). For example, in the USA the federal waivers allow states to implement more flexible reimbursement models and expanded coverage of home telehealth and remote monitoring services. Some states include specific provisions for home video visits while others cover remote data monitoring.
States may also apply for federal demonstration programs such as "Money Follows the Person" (MFP), which allocates federal funding for transitioning Medicaid beneficiaries from institutions to the community. Originally authorized under the 2009 American Recovery and Reinvestment Act (ARRA), the MFP demonstration program strengthens a state's Medicaid program to provide home and community based services to people who choose to transition out of institutions such as hospitals and nursing homes. Seventeen states have used at least one of the aforementioned options to provide some form of home telehealth under their Medicaid plans: Alabama, Alaska, Arizona, Colorado, Indiana, Kansas, Kentucky, Minnesota, New Mexico, New York, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Washington, and Wisconsin (see Table 1 and Figure 2).
Table 1
Usage of RPM in real world
State Video Con fe rent in к Remote Monitoring
A la ha ma ✓
Alaska ✓
Arizona ✓
Colorado i/
Indiana ✓(authorized)*
Kansas ✓ ✓
Kentucky ✓
Minnesota ✓ ✓(equipment rental only)
New Mexko ✓
New York ✓ i/
Pennsylvania ✓
Suuth Carolina i/
South Dakota i/
Texas ✓ (authorized)*
Utah ✓
Washington ✓ ✓
Wisconsin ✓
PHASE 1: COLLECT
I Activation: Patient, caregiver, clinician or third-party activates or initiates device for passive data collection
I Obtaining data: Activated device passively or actively collects information, which is recorded and stored for viewing and/or delivery
I Packaging data: Data is packaged in the appropriate formal for transmission
PHASE!: TRANSMIT
Delivery: Daia transmitted via Internet, telephone, text message or other electronic method
Receipt: Appropriate provider, caregiver or third-party receives patient data from device
Indicators programmed: Indicators of thresholds and normal results programmed into algorithm or noted if reviewed by a clinician.
PHASE 3: EVALUATE
Data review: Indicators are used to screen data for areas of concern, either by using an algorithm to compile results or a clinician to tabulate the information.
Alert preparation: Device, intermediary software or healthcare worker prepares the alert for transmission to care team via Dhone, text. Daaer or e-mail. In acute events.
Figure 2. Business Model Interactions
Patients Right Act
On February 25, 2013, Germany promulgated an Act Improving the Rights of Patients (hereinafter Patients' Rights Act). The Act creates the "treatment contract," a special contract that by law now governs every relationship between a person administering medical treatment and the patient. Although the law is aimed primarily at physicians, its scope encompasses also other health care professionals (C. Katzenmeier, Der Behandlungsvertrag - Neuer Vertragsatypus im BGB (The Treatment Contract - New Type of Contract in the Civil Code), Neue Juristische Wochenschrift 817 (2013)).
The detailed new provisions are inserted into the Civil Code (Bürgerliches Gesetzbuch, repromulgated Jan. 2, 2002, BGBl I at 42) as sections 630a through 630h, and they regulate the rights and duties of the "treating person" (hereinafter physician) and the patient on issues such as medical consent, disclosure, record-keeping, and the burden of proof when liability for treatment errors is claimed. Many of the rights granted to patients by the new legislation had already been developed by case law and non-binding guidelines (Dieter Hart, Patientenrecht nach dem Patientenrechtegesetz, Medizinrecht 159 (2013)), yet it is expected that their codification will make it easier for patients to know their rights (Press Release, Bundesministerium der Jutstiz (Federal Ministry of Justice), Patientenrechtsgesetz passiert den Bundesrat (Patients' Rights Act Passed in Federal Council), (Feb. 1, 2013)).
Access to Health Records Act 1990
Anyone with a claim arising out of the patient's death can apply for access to the records, but this may be declined if, during life, the patient forbade such disclosure. This Act has, to a great extent, been superseded by the Data Protection Act 1998. When first enacted, it allowed patients access to their non-computerised medical records and to ask for inaccurate or misleading information to be corrected, but it is now confined to governing rights of access to the records of patients who have died (the DPA only provides access to information about identifiable, living individuals). Essentially, anyone with a claim arising out of the patient's death can apply for access to the records, but this may be declined if, during life, the patient forbade such disclosure or if the patient's doctor believes that the patient would not have consented to disclosure. Disputed claims to access must be resolved through the courts.
What is HIPAA?
The Health Insurance Portability and Accountability Act (HIPAA) was enacted in 1996 (Pub. L 104-191). Congress sought to streamline electronic health record systems while protecting patients, improving health care efficiency, and reducing fraud and abuse (34). The HIPAA Administrative Simplification provisions required the Department of Health and Human Services to establish national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addressed the security and privacy of health data (35).
How does the HIPAA Rule apply to telemedicine?
Issues regarding privacy and confidentiality in the medical realm are not necessarily different in a telemedicine. As with conventional medicine, a telemedicine clinician has the same duty to safeguard a patient's medical records and keep their treatments confidential. Storage of electronic files, images, audio/video tapes etc., needs to be done with the same precaution and care ascribed to paper documents.
One unique challenge for telemedicine is to balance the requisite expansion of manpower to manage an electronic system with the increased number of people who have potential access to a patient's records. Telemedicine, at least at present, will require a technical staff to run the system that is completely independent from the medical team. Additionally, because of technological constraints, the transmission of information over communication lines lends itself to hackers and other potential exposure. Protocols must be scrupulously followed to ensure that patients are informed about all participants in a telemedicine consultation and that the privacy and confidentiality of the patient are maintained, as well as ensuring the integrity of any data/images transmitted.
Patients may also be sceptical about the use of video images and the idea of "unseen persons" during their exams. Additionally, fears about the reliability of the technology and the potential devastation that loss of the
information would cause, leave some wary of telemedicine. However, these concerns over the technology can be addressed through a combination of legal, technical and administrative security measures and patient education.
Right of access to personal data. To be informed by any data controller whether personal data of which that individual is the data subject are being processed by or on behalf of that data controller.
• If that is the case, to be given by the data controller a description of
o The personal data of which that individual is the data subject.
o The purposes for which they are being or are to be processed.
o The recipients or classes of recipients to whom they are or may be disclosed,
• To have communicated to him in an intelligible form
o The information constituting any personal data of which that individual is
the data subject, and
o Any information available to the data controller as to the source of those
data.
Where the processing by automatic means of personal data of which that individual is the data subject for the purpose of evaluating matters relating to him such as, for example, his performance at work, his creditworthiness, his reliability or his conduct, has constituted or is likely to constitute the sole basis for any decision significantly affecting him, to be informed by the data controller of the logic involved in that decision-taking.
• A data controller is not obliged to supply any information under subsection (1) unless he has received
o A request in writing, and
o except in prescribed cases, such fee (not exceeding the prescribed maximum)
as he may require.
The developers of «Health monitor» system thank the CJSC «AhTh» and National Research University Higher School of Economics for a tight and productive cooperation and the support of the Ministry of Education and Science of Russian Federation (the contract № 02. G 25.31.0033) without which it would be impossible to complete the research. References
1. Case Study, Blood Pressure UK
http://www.bloodpressureuk.org/microsites/kyn/Home/AboutKYN/Casestudies/Ineverreallythoughtabout/bloodpre ssure
2. CHRONIC CORONARY ARTERY DISEASE IN OLDER ADULTS, http://www.cardiosource.org/ACC/ACC-Membership/Member-Sections-and-
Councils/~/media/Files/ACC/Member%20Section%20Documents/ECCOA/Chronic%20CAD%20%20Case%201 %20of%201.ashx
3. Coronary Heart Disease: Family History of Father with Early CHD http://staff.washington.edu/sbtrini/Teaching%20Cases/Case%204.pdf
4. Elliot, W, John Hopkins Advanced studies in Medicine, A 38 year old with prehypertension, http://www.jhasim.com/files/articlefiles/pdf/ASM_7_12p383_386.pdf
5. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, European Heart Journal 2011. Vol. 32, P.2999-3054.
6. ESSENTIAL MESSAGES FROM 2013 ESH/ESC Guidelines for the management of arterial hypertension, http://www.escardio.org/guidelines-surveys/esc guidelines/GuidelinesDocuments/Web_EM_Hypertension_2013.pdf
7. Heart Foundation, Hypertension treatment: a case study, http://www.heartfoundation.org.au/SiteCollectionDocuments/Hypertension-case-study.pdf
8. Kerry General Hospital, Ratthas Tralee, Co Kerry, Essential information for Patients. http://www.hse.ie/eng/services/list/5/kerryhealthservices/kgh/patients/
НАУЧНОЕ ПЕРИОДИЧЕСКОЕ ИЗДАНИЕ «CETERIS PARIBUS» №1-2/2016 ISSN 2411-717Х
9. Knott, L. and Harding, M., General Prescribing Guidance 2014, http://www.patient.co.uk/doctor/general-prescribing-guidance
10.Nikodemus, M Shrestha, S Kumar, S.Liu, W. MIRAD Laboratory, April 25, 2013, Reducing Ambulance Dispatch Time, http://www.wpi.edu/Pubs/E-project/Available/E-project-042513-003855/unrestricted/SNLK3-FINAL.pdf
11.Report Ambulance care in Europe, Ambulances org Nederland, January 2010, http://www.eena.org/uploads/gallery/files/pdf/report-ambulancecare-in-europe-jan-2010%20(1).pdf
12.Suh, M.-k., Chen, C.-A., Woodbridge, J., Tu, M. K., Kim, J. I., Nahapetian, A., et al. (2011). A Remote Patient Monitoring System for Congestive Heart Failure. J Med Syst, 1-15.
13.Valeri, L., Giesen, D., Jansen, P., Klokgieters, K., Business Models for eHealth, 2010, http://ec.europa.eu/information_society/ehealth
© Shalkovsky A.G., Mikhaylova A.G., Vorobyeva E.E., Antonova K.A., 2016
