Abstract
Early diagnosis and slow progression of chronic diseases are important to improve the quality of life of patients. Physicians and patients can use medical systems to aid the detection and treatment of chronic diseases. In ours previous research, a medical system to aid the early diagnosis of the Chronic Kidney Disease (CKD) was developed. However, the current research is concerned with the evaluation and certification of medical system. Regulatory agencies define requirements to approve medical systems to market. The requirements in most of regulatory agencies are defined by prescriptive standards in a process-based approach. This approach alone is not enough to prove systems' dependability. On the other hand, there is a product-based approach in which one can use techniques such as formal methods to evaluate product properties. This chapter presents medical systems used to aid the detection and treatment of chronic diseases related to the stomach, heart, and kidney. Further, some challenges, solutions, and recommendations in the development and certification of this type of system are discussed.
TopIntroduction
The use of technologies in health care has been much researched in the last years. These technologies can include devices embedded on the environment, and personal devices, such as Smart Phones, Tablets, and Personal Digital Assistants (PDA). Physicians can use health care systems to assist the monitoring of patients in the hospital to verify and to analyze health data in order to avoid a risk situation. On the other hand, these systems can also benefit patients from the personal management of diseases. In addition, one can perform the remote monitoring of patients with mobility problems; and can improve the social inclusion of patients with chronic diseases (e.g. Chronic Kidney Disease (CKD)).
Some studies demonstrate the potential of using technologies to aid the health care. For example, Pang and Chen (2009) describe a solution for medications non-compliance. Further, Kulkarni and Ozturk, (2011) presents a software system for monitoring patients using wireless sensors. Nardini et al. (2011) proposes a middleware for coordinating services and security with runtime adaptation, and the application in health care for coordination of Electronic Health Record (EHR). These and other efforts show the need of monitoring and management of clinical information. Monitoring and management provide a better understand of patients about their health situation. Besides, there are health care technologies used to perform the treatment of patients.
In this context, medical systems must be safe and effective because faults can result in health problems. Health problems include physical damage and death. Software and hardware devices compose medical systems. We define “medical systems” as a set of medical applications, and software-controlled medical devices. The number of devices and applications is related to the probability of failure and complexity of the system (Bagade et al., 2013). One must also take into account the interaction of human-device and device-device. The interactions between physical and computational capabilities are related to Cyber-Physical Systems (CPS) (Majikes et al., 2013). CPS combines device with embedded software and computational and communication resources to monitor and to control the physical world (Baheti & Gill, 2011). The integration of devices, human, and environment generates emergent properties, such as security and safety. These properties must be evaluated by the interaction of systems (Systems of Systems - SoS). Thus, it is necessary the evaluation and certification of medical systems before commercialization to avoid risks to the safety of patients (Sokolsky et al., 2011).
In ours previous research, we developed a medical system named MultCare (Sobrinho et al., 2012; Sobrinho, et al., 2013a; Sobrinho et al., 2013b; Pinheiro et al., 2013). Multcare is a system to aid the early diagnosis of the CKD. However, we are currently concerned with the evaluation and certification of medical systems to avoid risks to the safety of patients. Certification of medical systems plays an important role to improve the acceptance, confidence, and safety of patients. This occurs due to the use of devices with different proposes in the diagnosis and treatment of patients, such as insulin infusion pumps and Electrocardiographs (ECG), and the integration of computational and physical aspects in medical systems (Medical Cyber-Physical Systems - MCPS).
Regulatory agencies, such as Food and Drug Administration (FDA)1 on the USA, Therapeutic Goods Administration (TGA)2 in Australia, and National Agency for Sanitary Vigilance (ANVISA)3 in Brazil, define requirements to approve medical systems to market. These regulatory agencies usually define rules and requirements to be met during the lifecycle process in the development of medical systems.
Key Terms in this Chapter
Mobile Application: The developing applications for mobile devices including cell phones, PDAs and other devices.
Patient-Centered Application: It is a type of application that has as focus in its development the needs of the patients in which will use the solution.
Ad Hoc Network: It is the possibility of connection and communication between devices without the use of a dedicated network infrastructure.
Wireless Sensors: It consists of wireless devices that collect context or personal information.
Wireless Network: It consists of a wireless technology to connect devices through the air as physical medium.
Diabetes Mellitus: Is a metabolic disorder characterized by an abnormal increase in blood glucose. The excess glucose can bring various health complications such as heart attack, stroke, kidney failure, vision problems, foot amputation and difficult to heal injuries, among others.
Hypertension: Is a chronic disease determined by high levels of blood pressure in the arteries, which causes the heart has to exert a greater effort than normal to circulate blood through the blood vessels. Hypertension is a major risk factor for the occurrence of strokes, heart attacks, aneurysms of the arteries, peripheral arterial disease, besides being one of the causes of chronic renal insufficiency.
Chronic Kidney Disease: Is the slow loss and permanent damage of kidney function, which leads to a buildup of fluid and waste in the body. This disease affects most body systems and functions, including the production of red blood cells, blood pressure control, the amount of vitamin D and bone health. Diabetes and hypertension are the two most common causes and responsible for most cases.
Colored Petri Nets: Petri nets are a formal method with a mathematical foundation and a graphical representation, for the specification and verification of concurrent and complex systems.