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× Regulatory Affairs ヘルスケアとIoT;日本の関連法規制 Healthcare × IoT Kiyoyuki Chinzei, Ph.D. (AIST Japan) 鎮西 清行(産総研) © K. Chinzei, AIST CC-BY-SA-4.0 Part of English translation is original and personal, not supervised by adequate authorities.

Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

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Page 1: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

× Regulatory AffairsヘルスケアとIoT;日本の関連法規制

Healthcare × IoT

Kiyoyuki Chinzei, Ph.D. (AIST Japan)鎮西 清行(産総研)

© K. Chinzei, AIST CC-BY-SA-4.0

Part of English translation is original and personal, not supervised by adequate authorities.

Page 2: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

© HRI/AIST

Keywords

Software as Medical Device医療機器プログラム

遠隔診療

electronic Informed Consent電子的インフォームドコンセント

SaMD

Tele-medicine

eIC

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Small Computings for Clinicals

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Ex: Endoscope Video Processor

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Hardware : PC, Tablet…

Software : SCC App

Commodity

Software as Medical Device

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Healthcare × IoT ×

Page 7: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

SaMD border

Tele-medicine

Privacy vs use

eIC

医療機器プログラム該当性

遠隔診療 個人情報保護 vs 利活用

電子的インフォームドコンセント

© HRI/AIST

Healthcare × IoT × RA : Topics

- PMD Act

- Medical Practitioners’ Act

- Personal Information Act

- Research Ethics Guideline

PMD Act = Pharmaceuticals and Medical Devices Act = 医薬品医療機器法,薬機法(旧薬事法)Medical Practitioners’ Act = 医師法Act on the Protection of Personal Information = 個人情報保護法Ethical Guidelines for Medical and Health Research Involving Human Subjects = 人を対象とする医学系研究に関する倫理指針

薬機法

医師法

個人情報保護法

人を対象とする医学系研究に関する倫理指針

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PMD Act 2013• Introduction of ‘Software as Medical Device’薬機法への「プログラム医療機器」の導入

• Definition?• SaMD [source: IMDRF/SaMD WG/N10FINAL:2013]

software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device

• Computer program [source: PMD Act 2013]something expressed as a set of instructions written for a computer, which makes the computer function so that a specific result can be obtainedプログラム:電子計算機に対する指令であつて、一の結果を得ることができるように組み合わされたもの

 → SaMD is a part of ‘computer program’.

PMD Act = Pharmaceuticals and Medical Devices Act = 医薬品医療機器法,薬機法(旧薬事法)

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SaMD vs. non-SaMD Health Software

Software

Health Software

Standalone Software

Medical Device

Software

Software installedin medical device

Software under old PAL

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SaMD vs. non-SaMD Health Software

Software

Health Software

Standalone Software

Medical Device

Software

Software installedin medical device

Software under new PMD ActSaMD

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PMD Act 2013• Introduction of ‘Software as Medical Device’

✓ Border of SaMD?✓ Safety of not-regulated standalone health software?

PMD Act = Pharmaceuticals and Medical Devices Act = 医薬品医療機器法,薬機法(旧薬事法)2014/11/14 薬食監麻発1114第5号「プログラムの医療機器への該当性に関する基本的な考え方について」

‘Basics of applicability to SaMD’notice 1114-5, 2014/11/14

2014/11/14 薬食監麻発1114第5号「プログラムの医療機器 への該当性に関する基本的な考え方について」

薬機法への「プログラム医療機器」の導入

Original and personal translation

Page 12: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

• Software for Class-I device is excluded.生命及び健康に影響を与えるおそれがほとんどないもの = クラスⅠは医療機器の範囲から除外されている(薬事法施行規則)

• Applicability of PMD Act to software is considered by プログラム医療機器の該当性の判断を行うに当たり、考慮すべき点

1. Degree of contribution to diagnosis / treatment疾病の治療、診断等にどの程度寄与するのか

2. Overall risk due caused by failure of the function不具合を含めた総合的なリスクの蓋然性がどの程度あるか

© HRI/AIST

‘Basics of applicability to SaMD’ Notice

2014/11/14 薬食監麻発1114第5号「プログラムの医療機器への該当性に関する基本的な考え方について」

Original and personal translation

Page 13: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

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‘Basics of applicability to SaMD’ Notice

2014/11/14 薬食監麻発1114第5号「プログラムの医療機器への該当性に関する基本的な考え方について」

Applicable1. Modify medical device

data 医療機器で得られたデータを加工

• Image workstation…

2. Assist treatment治療計画・方法の決定を支援する

• Simulation• Surgical planning• Dose computation

Not Applicable1. Store, transfer, show

medical device data医療機器で得られたデータを転送、保管、表示

2. Education, instruction教育用、患者説明用

3. Maintenance, finance logistics

4. Health management健康管理用

5. Software for Class-I device

Original and personal translation

Page 14: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

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Safety of non-SaMD Health Software

Software

Health Software

non-SaMDHealth

Software

Standalone Software

Medical Device

Software

SaMD

Software installedin medical device

Page 15: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

non-SaMD Health Soft

Risk is not 0/1 between the SaMD border.

© HRI/AIST

SaMD Border and Safety Measures

2014/08/01 GHS Promotion Council “Good Health Software development guideline” / ヘルスソフトウェア推進協議会「ヘルスソフトウェア開発ガイドライン」

Device SoftwareSaMD

outside  PMD  Act under  PMD  Act

negligible

risk

Risk

Page 16: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

non-SaMD Health Soft

Risk is not 0/1 between the SaMD border.

© HRI/AIST

SaMD Border and Safety Measures

2014/08/01 GHS Promotion Council “Good Health Software development guideline” / ヘルスソフトウェア推進協議会「ヘルスソフトウェア開発ガイドライン」

Device SoftwareSaMD

outside  PMD  Act under  PMD  Act

negligible

risk

Risk

non-SaMD Health Softwith some risk

Page 17: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

non-SaMD Health

Good Health Software development guideline voluntarily applicable to non-SaMD Health Software

© HRI/AIST

SaMD Border and Safety Measures

2014/08/01 GHS Promotion Council “Good Health Software development guideline” / ヘルスソフトウェア推進協議会「ヘルスソフトウェア開発ガイドライン」

Device SoftwareSaMD

outside  PMD  Act under  PMD  Act

negligible

risk

Original and personal translation

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http://good-hs.jp

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IoT × Tele-medicine ×

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IoT × Telemedicine × RA• Regulated by Article 20, Medical Practitioners’ Act

Article 20 No medical practitioner shall provide medical care or issue a medical certificate or prescription without personally performing an examination…第二十条 医師は、自ら診察しないで治療をし、若しくは診断書若しくは処方せんを交付…してはならない。

✓ What extent ‘personally performing’ is interpreted?

Medical Practitioners’ Act = 医師法1997/12/24 健政発1075号通知「情報通信機器を用いた診療(いわゆる「遠隔診療」)について」2015/08/10 医政局長事務連絡 「情報通信機器を用いた診療(いわゆる「遠隔診療」)について」

‘On medical care through ICT device (aka tele-medicine)’ notice, 1997/12/24

… restrictive

Revised notice, 2015/08/10

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‘Tele-medicine’ revised notice, 2015/08/10• Cases stated in the 1st notice 1997 meant ‘examples’.平成9年通知において、「直接の対面診療を行うことが困難である場合」「別表」を挙げたが、これらは「例示」であるとした。

✓ Remote island patient, etc.✓ Outpatient diabetes, etc.

• Per upon the patient’s demand, with carefully weighing the patient’s benefit, tele-medicine is applicable.患者側の要請に基づき、患者側の利点を十分に勘案した上で、直接の対面診療と適切に組み合わせて行われるときは、遠隔診療によっても差し支えない

2015/08/10 医政局長事務連絡 「情報通信機器を用いた診療(いわゆる「遠隔診療」)について」

Applications of tele-medicine with IoT

Original and personal translation

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Healthcare × Big Data ×

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Healthcare × Big Data × RA

• Research & Development taking advantage of IoT?

Data acquisitionデータ収集

Subject enrollment被験者募集

electronic Informed Consent (eIC)電子的インフォームドコンセント

Ethical Guidelines for Medical and Health Research人を対象とする医学系研究に関する倫理指針

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electronic Informed Consent (eIC)• The Guidelines;

Data acquisition involves sampling byInvasiveIntervention, orHuman biological specimens else

• The Guidelines Q&A;It is not assumed to obtain a written consent by electromagnetic means e.g. by e-mail, because such cannot be recognized by human perception and the counterfeit identification issue remains.なお、自由意思に基づく文書による同意は、現段階においては、なりすましの防止等の課題があるため、電子的方式、磁気的方式その他人の知覚によって認識できない方式によること(電子メール等による同意)は想定していない

Ethical Guidelines for Medical and Health Research Involving Human Subjects = 人を対象とする医学系研究に関する倫理指針Guidance for the Ethical Guidelines, revision March 31st 2015 = 人を対象とする医学系研究に関する倫理指針ガイダンス

• ‘Written’ consent required

• ‘Verbal’ consent acceptable

• IC not required

Original and personal translation

Page 25: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

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electronic Informed Consent - FDA / Apple

FDA Draft Guidance “Use of Electronic Informed

Consent in Clinical Investigations”ResearchKit  An  opensource  framework

ResearchKit and the ResearchKit logo are trademarks of Apple Inc.

Released on March 9, 2015

• ResearchKit does not strictly conform FDA guidance.• ResearchKit Apps reported 100k+ subjects in a day!

Page 26: Healthcare IoT Regulatory Affairs...Healthcare × IoT × RA : Topics-PMD Act -Medical Practitioners’ Act-Personal Information Act-Research Ethics Guideline PMD Act = Pharmaceuticals

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Healthcare × IoT × Regulatory Affairs• Related regulations

- PMD Act 2013- Medical Practitioners’ Act- Personal Information Act- Research Ethics Guideline

• Matters Improved (?)- GHS development guideline ヘルスソフト開発ガイドライン

- Tele-medicine notice relaxed.遠隔診療通知の緩和

- ‘My Number’ (Japan’s SSN)? マイナンバー?

- eIC draft guidance in US - Japan? 米FDAはeICガイダンス公表…

• Matters Arose- SaMD border and safety非該当ソフトの安全性

- Tele-medicine restriction 遠隔診療と医師法20条

- Big data and Privacyビッグデータ利活用と個人情報保護

- Subject enrollment and IoTIoTを活かした被験者データ収集

薬機法医師法個人情報保護法人を対象とする医学系研究に関する倫理指針