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1 17 th /Dec./ in TOKYO Late Majority security senryaku.pdf

2 P20 security senryaku.pdf 31 31

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12 FDA FDA Safety Communication (613) ( 鍵 NG) () ( 23 FDA Draft Guidance for Industry and Food and Drug Administration Staff (1/2) FDA614 Safety Communication Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff 912 URL /06/14/ /content-of-premarket- submissions-for-management-of- i f cybersecurity-in-medical-devices-draft- guidance Guidance URL /DeviceRegulationandGuidance/GuidanceDoc uments/ucm pdf 24

13 FDA Draft Guidance for Industry and Food and Drug Administration Staff (2/2) / 3. The type of documentation that we recommend you submit in your premarket submission is summarized in this section FDA [] portunity&mode=form&id=579ab &id 0f9fbf869ffe2cebb605fec27a2 WIFI WPA HTTP 26

14 LIXIL - Trustwave81LIXIL AndroidMy SATIS Bluetooth th PIN SATIS BluetoothPIN 0000 My SATIS SATIS / Cyber security

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16 ISO/IEC ISO13485ISO9000 ISO9000 ISO14971 IEC62304TC nd Edition TC215JWG7 IEC IEC Step by step/-2security/-3mobile) /-4HDO /-5Alarm /-6Responsibility Agreement IEC/TR ISO14971IEC62304 IEC62366 IEC MDMedical Software System JAHIS IEC Part 1 Application of risk management for IT-networks incorporating medical devices Part /2/33TR 1/2/33TR 2012/ TR IS Step by Step Security : 2010/ HDO 2012/E AAMI Horizons Fall RA 2013/9 Part 3 32 Wireless NW HDO Guidance Responsibility Agreement Alarm

17 JAHIS 33 (Risk Analysis) (vulnerability) (Risk) (threat) (countermeasure) (Risk Assessment) Residual Risk

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20 23 and Me 23 and Me Me Privacy Statement

21 23 and Me 23 and Me multiple SNPs l analysis SNPs SNPs960, Health Risks 50 Inherited Conditions 59 Traits 23 Drug Response DNADNA Dry, Wt Wet Locked Report

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