Brazilian General Data Protection Law (LGPD), in effect since May, 2021, regulates how to process personal data of citizens in Brazil. On the whole, it aims to keep data safety and eliminate sharing unauthorized by owner.
As telemedicine spreads in the country, medical offices, clinics and other healthcare institutions are legally obliged to follow LGPD rules. Otherwise, infringement fines may reach high values.
Therefore, it is imperative for data exchange, online consultations and exam delivery for reporting, among other medical practices, to occur in reliable and safe environments. Furthermore, the law considers data on patient healthcare as sensitive.
“The great change with LGDP relates to the concept of property of medical data. These data no longer belong to healthcare institutions. Now they exclusively belong to the patient. However, institutions are responsible for data security”. – explains Phelcom’s Data Engineering manager, Fernando Yamanaka.
For this reason, data security is a priority in Phelcom. All images made with Eyer handheld fundus camera and stored in EyerCloud, online platform to manage exams, are protected by Amazon Web Services (AWS). This computing services has the most credible database and cloud systems in the market.
“We store retina images from millions of patients. This part of the eye is known as an ‘eye fingerprint’, since it is unique for each person. That’s why we use the best information security practices to protect data from patients of our customers”, he says.
More than LGPD, Phelcom follows the rules of Health Insurance Portability and Accountability Act (HIPAA), a law on portability and accountability of health insurance in the United States.
Eyer is also sold in the USA. Recently, the FDA (Food and Drug Administration) approved the handheld fundus camera in the category 510(k), the highest for retinographs. Part of the regulatory process involved cyber security analyses of Phelcom’s device.
HIPAA Compliance establishes rules to protect electronic records and medical data of patients. With regards to the LGPD, it has similar goals: protect patient privacy, oblige entities to make medical records available when prompted and assure that patients are notified in case of leakage of sensitive data.
Eyercloud is an online platform integrated to Eyer that allows storing and managing patients’ exams. All data the equipment captures can automatically synch to the system, so that they are uploaded with full security.
More than assuring data backup in a secure server, the user has all data organized in a friendly, functional and intuitive interface.
For instance, the tool enables evaluation of images by EyerMaps, an innovative system of Artificial Intelligence (AI) that detects any suspicious retinal abnormalities with high accuracy.
In a few seconds after capturing the fundus photo, if a suspicious alteration is detected, the AI generates a new image with a heat map, highlighting the potential abnormalities in the retina. Synchronized with EyerCloud, it classifies the captured images and exams in a simple and visual way, according to the probability of alteration, using colored markers:
- Green: image or exam with low probability of alteration (up to 30%);
- Yellow: image or exam with medium probability of alteration (31 to 70%);
- Red: image or exam with high probability of alteration (71 to 100%).
Eyercloud helps doctors to make reports quickly, prioritize urgent cases and share all data, either printed or by e-mail, with the patients, by generating a protocol number and password.
“We invested in a complex infrastructure to secure the sensitive data of our patients. This is one of the main advantages of EyerCloud. At present, our platform stores about two million exams”, highlights Yamanaka
The manager explains that keeping sensitive data of patients in computers or storages of easy access and in unprotected systems may be risky. “Cloud systems with high security, as EyerCloud, are an essential investment to protect doctors, medical offices, clinics and hospitals from leakage of sensitive data and, consequently, from probable penalties from LGPD”.
Eyer Handheld Fundus Camera
Eyer is a portable fundus camera that works coupled to a smartphone and makes high-quality retinal exams in a few minutes, without need of pupil dilation.
The technology helps to diagnose more than 50 diseases, such as glaucoma, cataract, diabetic retinopathy, DMRI, retinoblastoma, hypertensive retinopathy and ocular toxoplasmosis. It is available in Brazil, United States, Japan, Chile, Colombia and, soon, in other countries.
Portability, connectivity and integration to intelligent functions as EyerMaps, as well as the lower cost of the technology, contribute to increase access to retina exams.
Phelcom Technologies is a Brazilian medtech headquartered in São Carlos, upstate São Paulo. The company history started in 2016, when three Young researchers – a physicist, an electric engineer and a computing engineer (Physics, ELetronics, COMputing) – created a handheld fundus camera integrated to a smartphone.
The project of the first prototype was born from the interest of the partner Diego Lencione on visual health. His brother has a condition that severely compromised the retina and vision since childhood.
In 2019, Phelcom lauched its first product in Brazilian market: Eyer handheld fundus camera. Nowadays, the technology has already reached more than two million people all over Brazil and the countries it is present.
In four years, the company already took part of more than 100 social actions and, recently, has been ellected one of the 10 most innovative companies in Brazil by Forbes.