REGULATORY UPDATE | Alat Kesehatan Nirkabel

The development of wireless technology in this world has made the era of medical devices enter a new era, namely making them wireless, which improves the quality of life of patients who have various diseases for the better. The shape of medical devices has now been made smaller or become portable and is not only a form but a system. diagnostic, monitoring, and treatment systems, which provide many advantages compared to medical devices that have a large size and a form that has become portable, also reducing costs and inconvenience for health care providers. With the arrival of this wireless medical device causing new concerns, what does this concern mean? It means great security against exploitation by malicious hackers. We will explain the advantages and disadvantages of these wireless healthcare tools and assess the diversity and severity of security threats.

Advantages of Wireless Medical Devices

electronic technology that already has a very low power consumption system and fast performance, making it feasible in markets that were previously uninhabitable, especially in the medical world. A new era of medical care is rapidly developing, with the help of leading research institutes and companies developing micro-sized, ultra-thin, flexible, and biocompatible electronics. With this development, wearable or implantable biomedical devices will achieve the same functionality with reduced patient discomfort and lower costs for healthcare providers.

The important thing about this new era of health technology is the ability to communicate with very low power consumption and can be operated remotely and data can be accessed remotely. Bluetooth released a new platform called Bluetooth Low Energy (BLE), which aims to provide devices with wireless communication at aggressive power metrics and low cost without sacrificing performance relative to other wireless standards.

Disadvantages of Wireless Medical Devices

With the development of medical devices, patients can reduce the burden of visiting the hospital, which reduces the cost of treatment drastically for both the hospital and the patient. These mobile medical devices have a security risk, i.e., Transmission of data across a wireless network presents a glaring security vulnerability if a malicious hacker can penetrate network security and gain access to confidential patient information. Hackers can hijack device operations to steal personal information or cause damage to devices. To prevent this, you can use wireless protection such as wireless encryption, data access control, and password confidentiality.

Regulation of Wireless Medical Devices in Indonesia

For registration of wireless medical devices in Indonesia, one must have a certificate of telecommunication equipment which must be licensed by the directorate general of SDPPI. Applications for telecommunication equipment certificates can be submitted by brand owners who are Indonesian legal entities, Indonesian business entities appointed as official distributors by brand owners domiciled outside the territory of Indonesia, Indonesian legal entities that manufacture telecommunication tools or equipment for brand owners domiciled outside Indonesia. the territory of Indonesia, an Indonesian business entity that makes, composes, and combines components of telecommunication equipment so that it can function as telecommunication equipment.

Before making an application for a telecommunication equipment certificate, the registrant must have an OSS account, After having an OSS account, login then select commitment to permit or commercial telecommunication equipment certification to get an NIB. After getting an NIB, the applicant must register an account using email via the website KOMINFO service. The applicant logs in to the website DITJEN SDPPI by using the registered account and inputting the NIB and completing the file required for PLG ID registration. After the file is verified, The applicant will get PLG.ID then go to the website KOMINFO service and register email, go to webiste DITJEN SDPPI then login and enter NIB, register PLG.ID and verify. To find out the complete certification procedure, visit e-Certification | Information (postel.go.id). Layanan KOMINFO. Pemohon melakukan login di situs web DITJEN SDPPI dengan menggunakan akun yang telah didaftarkan dan menginput NIB serta melengkapi berkas yang diperlukan untuk pendaftaran PLG ID. Setelah berkas diverifikasi, Pemohon akan mendapatkan PLG.ID lalu pergi ke website Layanan Kominfo dan Lakukan registrasi Email, Pergi Ke Webiste DITJEN SDPPI lalu login dan masukan NIB, lakukan Registrasi PLG.ID dan verifikasi. Untuk mengetahui Prosedur Sertifikasi lengkapnya kunjungi di e-Sertifikasi | Informasi (postel.go.id).

What are the Requirements for Telecommunication Equipment Certification

To make a telecommunication equipment certificate, you must complete several requirements. For a new application, you must have a test result report and several documents, technical specification documents and more. again and for the application for change of certificate must have the original SDPPI certificate. For more complete information, visit the website e-Certification | Information (postel.go.id) e-Sertifikasi | Informasi (postel.go.id)
.

The certification fee is divided into two based on the test result report attached to the application. For the attached test result report issued by the domestic test center, a fee of IDR 7,000,000 (seven million rupiah) is imposed. And for the attached test result report issued by an overseas test center, a fee of IDR 50,000,000 (fifty million rupiah) is imposed.e-Sertifikasi | Tarif Sertifikat (postel.go.id)The test result report will still be stated and can be used in the Telecommunication Equipment certification process as long as the technical reference used in the test has not been changed (revised and declared invalid).

The applicant must make a payment no later than 5 (five) working days after the certification is issued before the certificate is revoked, declared invalid, and the applicant must process the application from the beginning.