technology
Milan , April 22, 2014 – 9:24
There’s really something for everyone and it seems not a day without it creation of a new: there are now app (software installed on mobile or tablet) to remind you when to take medications, doctor’s appointments or vaccinations, to keep a food diary and help us lose weight, to monitor pressure or blood sugar, to help you quit smoking. These are just a few examples, because it seems there is no limit to the imagination of the developers: according to the latest estimates available medical apps for smartphones and tablets are already more than 40 thousand and growing at a phenomenal rate, so that for these tools suggest 500 million users by 2015, while in 2018 half of all smartphone users in the world have downloaded at least one mobile medical app. In this endless sea of ??applications of all kinds lose the compass seems more than likely: it is not surprising that the European Union has published a few days ago a Green Paper on “mobile health” (open to the public consultation and suggestions for changes of up to 2 next July), which will also address the app sector, trying to figure out how to regulate it, for example to ensure the protection of personal data, the rights and safety of patients. An integral part of the Green Paper is also a guidance document for developers, who are often unaware of the legal implications of their products, along the lines of a similar one approved last September by the Food and Drug Administration with the aim of giving precise directions.
Some apps, for example, are considered by the FDA as real medical devices, and as such should be subject to stringent rules. They are, for example, the app that transforms your smartphone into a sort of portable electrocardiograph for diagnosis of arrhythmia, or those that are used to manage diabetes, giving directions on how to change your insulin according to blood glucose measurements. In these cases, the U.S. agency that requires the app to be subjected to a review process before being put on the market, it must instead for applications with less direct implications on the health of consumers, for example because they help to manage a chronic disease without however, give indications of treatment, because they give only information about the disease or simply because they facilitate the interaction between patient, doctors and health care facilities. The rules are necessary because, though at first glance the idea of ??downloading an app treatment on the phone may seem harmless, some risks do exist for patients, and how. “One of the most critical is the use by a generic user-patient relationship that may not have adequate knowledge and skills – said Marcella Marletta, general manager of the medical devices, pharmaceutical service and safety of care to the Ministry of Health -. This can lead to errors and oversights that alter the function of the app, or misinterpretation of the data or results obtained, thus facilitating diagnosis and therapies “do it yourself” that can have serious effects on health. In addition, with an increasingly wide and diverse apps there are difficulties and potential dangers as well when deciding if it is not carried out on the advice of the doctor, it is common to have doubts and concerns about the quality of the app downloaded or spend hours on the many “app store” to research, often fruitless, for the “right” according to its own criteria for self-diagnosis or their needs, which is not necessarily the real ones are. “
That said, it clear, however, the positive potential medical apps: many can streamline the doctor-patient relationship, to facilitate the use of telemedicine to reduce health care costs, help the chronically ill to follow better therapies. And according to the World Health Organization, 80 percent of cases of diabetes, cardiovascular disease and stroke could be prevented just with better self-care, which means the app could become a simple and affordable for everyone. To achieve this, however, must have a ‘stamp of quality’: patients’ associations have expressed themselves in this way on the platform MyHealthApps, dedicated to the “review” of medical applications, asking for a definition and standard rules. “The Ministry of Health has initiated a number of projects on this line: once the monitored current situation from the perspective of regulatory, technological and procedural arrive at a proposal for the classification of health app in a special register – says Marletta -. In addition, the integration will be defined regulations necessary to have proper and specific rules will be created a “Web Portal Service” experimental, procedures and controls for “certification” of medical apps, where developers can also find directions and guidelines “. “Today – he continues Marletta – consider software as medical devices that are mounted on equipment designed to perform health functions, such as ultrasound or CT scan machines. The app, however, are software tools installed on the medical purposes such as mobile phones or tablet, built for completely different purposes. For this it is necessary to “drive” the industry, investigating the specificity and giving ad hoc rules. ”
Even patients not realize : In a study conducted a few months ago about 250 people from 16 countries, including the five characteristics that the majority considers essential prerogative of the medical app stand out its credibility and security, in addition to ease of use and real ability to help you take better control disease. Same requests from physicians, as noted by Ovid Brignoli, vice president of the Italian Society of General Medicine: “This is an evolution of medicine with many positive traits, but must be managed and regulated. The essential thing is that the doctor teaches the patient how to use the app more suited to his needs, in the most correct, staying by his side: they are useful tools, but they should never replace the relationship with the physician. They must promote and extend the communication, not cancel it or distort it. “
April 22, 2014 | 09:24
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