JIRA Activity Report

Report from Standardization Division

1. Introduction

The 3rd edition of IEC 60601-1 was published in December 2005. It introduced the technical progress and new concepts about risk etc., which emerged after the 2nd edition. After publication of the 3rd edition, the related collateral standards and particular (product) standards are revised to harmonize them with the 3rd edition. The related committees of Standardization Division deliberated the matter and sent positively the representatives to the IEC International Conferences so that Japan's opinion may be adopted. The 3rd edition of IEC 60601-1 will become mandatory in EU member states in 2012. In order to keep pace with this, Japan is to perform activities such as establishment of the corresponding JIS and countermeasures against the revised Pharmaceutical Affairs Law.

2. The development of IEC60601

The Steering Meeting of IEC SC62B Committee was held in Dublin in September 2005 to discuss how to address the SC62B-related standards in future. This meeting mainly discussed 1) how to harmonize product standards related to X-ray diagnostic equipment with the general requirements, and 2) how to handle the existing particular standards. As for the X-ray diagnostic equipment, the component-specific standards are to be changed to the system standard according to the following policies. As mentioned at the beginning, these particular standards are in the process of establishment.

1) IEC 60601-2-54 (System safety standard of X-ray equipment for radiography and fluoroscopy) will be established.

2) IEC 60601-2-63 (System safety of dental X-ray equipment) will be established

3) IEC 60601-2-43 (Standard for X-ray equipment for IVR) will be modified to become a system safety standard, which is to be used in conjunction with 60601-2-54.

4) IEC 60601-2-7 (X-ray high-voltage generators standard) will be withdrawn. (Particular requirements will be moved to each system safety standard.)

5) IEC 60601-2-32 (Mechanical safety) will be withdrawn. (It will be incorporated into the 3rd edition of parent standard, and will be moved to each system safety standard.)

6) IEC 60601-1-3 (Radiation protection in X-ray equipment) will be modified significantly. (Particular requirements will be deleted, and be moved to each system safety standard.)

Particular standards related to SC62B

Fig.1 Establishment of system standards related to medical diagnostic imaging equipment

3. IEC/TC62/SC62 in June 2009, Participation in Brussels international conference

The international conference of IEC TC62(Technical Committee 62) and SC62(Sub Committee) is held once in 12 to 18 months. It is a general meeting where the overall issues are deliberated and the progress of each SC deliberation is reported. Until now, Japan participated in the meeting mainly to gather information. At the international meeting held in June 2009, Japan proposed that "the essential performance" should be deliberated urgently. This is because of the following reasons. Only after particular standards were finally harmonized with the 3rd edition of IEC 60601-1, we started to incorporate it to domestic standards. Then, we found mistakes and misinterpretation when we incorporated the new concept of essential performance that was introduced into the 3rd edition.

About the essential performance, the parent standard gives definition and explanation. This concept is difficult to understand. We found that the particular standards did not fully understand the definition and handling. In order to point out the problems and demand revision, we cooperated with JEITA, which is a Japanese deliberation body of IEC 60601-1, and gathered comments. We contacted the National Committee. We pointed out the problems and demanded revision at the international meeting of IEC/TC62/SC held in Brussels. They understood the problems, and they forwarded the revision to A1PMT(Amendment 1 Project Maintenance Team) Committee, which is in charge of this issue. Later, JIRA participated in A1PMT Committee meeting held on September 30 through a telephone conference and presented our concrete revision draft. The presented draft was generally accepted. It is to be incorporated into Amendment 1 to the 3rd edition of IEC 60601-1. The draft of Amendment 1 is to be published in January 2010.

4. Activity for revision to the 4th edition of collateral standard IEC 60601-1-2 (EMC)

Revision of the 4th edition of IEC 60601-1-2 (EMC) is under deliberation by IEC 62A SC, and under deliberation by JEITA in Japan. The 4th edition is more demanding than the 3rd edition, in terms of requirements for medical devices handled by JEITA and JIRA. JEITA already submitted a request for modification or change. But, the request remained unaccepted. In August 2009, however, the revision draft was published. Even if Japan voted against the revision draft, it was unlikely that drafted was rejected. Therefore, we prepared a document that indicated our status of opposition to the draft and the problems of the draft. We send the document through the International Division to our counterparts, COCIR, NEMA-MITA, KMDIA (Korea Medical Devices Industry Association) /KMDICA (Korea Medical Devices Industrial Coop. Association) and CAMDI (China Association for Medical Devices Industry), respectively in the U.S., Europe, Korea and China. We intended to encourage them to vote against the draft.

An approval of the draft requires a majority of votes of P–members(Participating members) who are taking part in the planning of the said SC. Nine members voted for the draft. Other nine members voted against the draft. Still other nine members abstained. The affirmative votes were only 1/3. The number of abstainers was many, contribution to disapproval of the draft. JIRA's campaign succeeded as follows. The votes of COCIR members were: five against, one abstention, and four for the draft. China voted against and the U.S. abstained.

The draft was rejected. JIRA will dispatch a member to MT23(Maintenance Team 23) Committee Meeting of IEC/SC62A to be held in January 2010, and join deliberation about the future activity.

5. Future activity

During the 2010 fiscal year, the particular standards to be harmonized with the 3rd edition of IEC 60601-1 will be established. We join deliberation positively to express Japan's opinion. At the same time, we intend to make quick deployment into the domestic standards, JIS. The draft of Amendment 1 of IEC 60601-1 will be published in January 2010. It is necessary to confirm the contents of revision of “Essential Performance” as mentioned above, to deliberate the revision contents about basic safety, and to make the standard easier for us to use.

Medical Imaging System Division
Security Committee
Report of participation in SPC conference

1. Introduction

On September 29, 2009, they held the joint NEMA/COCIR/JIRA security and privacy committee conference (henceforth, SPC) was NEMA headquarters Rosslyn, Washington, the U.S. This report outlines SPC and the recent discussion.

2. What is SPC ?

SPC is the joint NEMA/COCIR/JIRA security and privacy committee. It is jointly established by medical equipment industrial associations in Japan (JIRA), the U.S. (NEMA) and Europe (COCIR). It addresses information security and privacy protection. The main activity is creation and publication of a white paper document about security and privacy protection.
JIRA is a member of SPC and joins periodically the conference. It participates jointly in creation of a white paper document. JIRA's Security Committee reviews SPC's draft of a white paper document, demands modification based on Japanese systems, points out technical issues, and proposes improvement.
SPC publishes the following white paper documents. JIRA posts the Japanese translation at JIRA's web page as follows.
(http://www.jira-net.or.jp/commission/system/index.html)

(1) Defending Medical Information Systems Against Malicious Software
(It outlines the defense measure against malicious software, such as virus etc.)

(2) Break-Glass: An Approach to Granting Emergency Access to Healthcare Systems
(It describes how to guarantee availability of system operation in emergency.)

(3) Remote Service Interface - Solution (A) - Version 2: IPSec(Internet Protocol Security) over the Internet Using Digital Certificates
(It introduces use of IPSec VRN(Virtual Private Network) as a measure to remote maintenance security.)

(4) Patching Off-the-Shelf Software Used in Medical Information Systems
(It summarizes the cautions to the user and vendor about patches of commercial off-the-shelf software.)

(5) Management of Machine Authentication Certificates
(It describes the node authentication using the public-key crypto system in absence of the PKI(Public Key Infrastructure) environment.)

(6) Information Security Risk Management for Healthcare Systems
(It describes necessity and procedure of information security management for healthcare systems. )

(7) Remote Services in Healthcare-Use Cases and Obligations for Customer and Service Organizations
(It illustrates use cases in remote service, and describes how manufacturers should meet the security and privacy requirements. )

3. The main, new topics

(1) New Work Item Proposal (NWIP) for The Association for the Advancement of Medical Instrumentation (AAMI) Guidance on the use of agile practices in the development of medical device software.
This was proposed, as Technical Information Report, to AAMI. It also pays attention to the relation with IEC 62304 (Standard of medical software quality criteria) or FDA (U.S. Food and Drug Administration).
When FDA makes assessment of medical equipment software, conventionally, each company applies for assessment according to individual approach. Assessment is made individually. But, this work is burdensome to small and medium enterprises. Guidance should be created in advance and standardization should be intended. This resulted in NWIP. At SPC conference of this time, the proposal was presented. The existing major vendors are allowed either to continue their own method or to comply with the guidance.

(2) Manufacturer Disclosure Statement for Medical Device Security (MDS2)
In order to explain that managers of medical facilities in the U.S. comply with the privacy rule of HIPAA (Health Insurance Portability and Accountability Act), medical equipment vendors issue disclosure statement of implementation of their products. MDS2 is a format of such a statement. This format uses a Yes/No answer for security questions to describe briefly the management situation of the electronic health information to be protected.
NEMA proposed to incorporate MDS2 into IEC 80001 (Application of risk management for IT-networks incorporating medical devices), which is a risk management standard over the medical equipment software to a user. As a result, MDS2 was adopted as an informative reference in the lst draft of IEC 80001, but was removed from the 2nd draft. So, NEMA intends to recover MDS2 as an informative reference, and to create a revised edition, which is more harmonized with IEC 80001. This matter is under discussion. The revised edition is featured with the expanded network security, which was missing in the past.
At SPC meeting of this time, NEMA wanted to revise MDS2 and to keep it available in IEC 80001-1. Discussion was held based on it. Originally, MDS2 was a standard to meet HIPAA and focused on confidentiality. In this discussion, most members pointed out that the scope should be expanded to include integrity. We had a heated discussion. Some members said that the concrete method should be described to ensure integrity. But, this was rejected, because a Yes/No type would produce a large number of questions. The issue of integrity has much to be solved. The requirements in Japan and EU are not always the same as in the HIPAA. NEMA is enthusiastic to adopt MDS2 as an informative reference, but Japan and EU are not so enthusiastic as NEMA.

(3) Revision of remote service white paper document
Discussion was held about the necessity for amendment of a remote service white paper document. Although it was proposed as a subject for discussion, users had no specific request for revision. A concrete examination was shelved.

(4) Introduction to the activity in Japan
From JIRA, the newest security-related trend in Japan was explained as follows.
First, the medical information network base study group of the Ministry of Health, Labour and Welfare (MHLW) released "the fourth edition of the guideline about the safety control of a medical information system" (safety control guideline). This guideline summarizes requirements for medical facilities. based on the so-called Personal Information Protection Law and the e Document Act.
Next, HPKI (health care public key infrastructure) was explained. MHLW specified the authentication policy for electronic signature certificates. The Medical Information System Development Center and Japan Medical Association are attempting to issue certificates. Furthermore, in this year, they are planning the authentication policy for personnel and organization. Once the authentication policy is completed, then the base of signature and authentication for health care would be completed with the reliable point placed at the Japanese government (MHLW).
Finally, as a future project, the demonstrative experiment of social security card was started. Japan has no ID, which corresponds to the U.S. social security number. So, Japanese people use different IDs for different purposes. Japan needs a framework to integrate different IDs.

International Division
Report of the 14th AHWP meeting

1. Outline

This is a report in outline of the 14th Meeting of the Asian Harmonization Working Party (AHWP) held on 5 and 7 November 2009 at Hong Kong, People 's Republic of China.

Up to now, this AHWP meetings have been held very actively under Malaysia Chair state and Singapore as practical organizer. This meeting was the first one after China has been officially nominated as Chair state. Before this plenary meeting (6th-7th), TC meeting and pre-meeting Workshop of each AHWP Work Group were taken place on 4th and on 5th, respectively. In this Workshop, many topics which would be useful educational subject for the AHWP members such as basic approach to MD regulation and its present situation in the GHTF economies were presented. An official expert of the office of Medical Device Evaluation of the Ministry of Health, Labor and Welfare of Japan presented the contents of the revised Pharmaceutical Affairs Law.

At the opening of the AHWP meeting, it was reported that participants were over 300 members from 27 member states including Chile and Peru of South America. Now the AHWP is beyond Asian bounds and it is becoming an organization of not only Asian area but all states other than the Global Harmonization Task Force (GHTF) participating states. Up to now, the following 20 countries are AHWP member states: Abu Dhabi, Brunei Darussalam, Cambodia, Chile, People 's Republic of China, Taiwan, Hong Kong, India, Indonesia, Jordan, Saudi Arabia, Korea, Laos, Malaysia, Myanmar, Philippine, Singapore, South Africa, Thailand, and Vietnam.

It was reported that the AHWP activities, especially in educational field, with cooperation of the APEC, provided 10 training courses regarding the GHTF Guidance Documents in various places since 1999 until now. Finally the Chair proposed that the next Forum would be held after about one year at Saudi Arabia. This proposal has been unanimously agreed on. Meantime the Chair stated to want to invite GHTF SC meeting or Conference.

2. Pre-meeting Workshop

Two years ago, in the pre-meeting Workshop of the 12th AHWP, the main task was to exchange information of MD industry and the real state of regulation of each country, but this time as the tendency to educate the AHWP members to the fundamental regulations was enforced, the following experts presented each topic of their own special field:

3. AHWP Meeting

3.1 Opening Greeting

AHWP Chair, Mr. Baoting Wang (SFDA(State Food & Drug Administration)), welcomed and thanked all participants for attending the 14th AHWP.

He pointed out the AHWP 's aim to promote the international Harmonization of pharmaceutical Regulations in Asian area and to study the regulations themselves, with reference to the GHTF 's activity of technical Harmonizing or APEC 's activity in the Medical Devices and Apparatus field. In concrete, this target is to introduce the Quality system, ISO Quality audit method to secure the MD safety, administrative report etc.

3.2 AHWP 's Work Plan

Xuejun Zhu of the AHWP Secretariat (CAMDI(China Association for Medical Devices Industry)) reported a wide range of activity plans from 2009 to 2011, which are the establishment of the AHWP TC 's framework and E-Newsletter publishing and Website renewal to improve TC 's work efficiency; annual comparison and summary of Member 's Regulatory systems together with the differences from GHTF rules; fulfillment of the AHWP Meeting and workshops; intense cooperation with the GHTF, APEC and WHO; setting up permanent Secretariat.

The detailed targets are: assessment of pilot implementation of CSDT( Common Submission Dossier Template) which is used for the pre-market judgment; mutual assessment of QMS auditing report, clinical evaluation data and type test results by different competent authorities; introduction of Safety Alert (SADS) and training; understanding and consensus of a single nomenclature system and UDI; establishment of a basic rule for the definition of medical device and manufacturer; establishment and enlargement of training system; publishing of an AHWP guidance document for QMS auditing and clinical evaluation .

3.3 TC Meeting Report

Joanna KHO in Singapore, the Chair state of TC, chaired the meeting and 8 TC WGs reported one by one every 10 minutes in consideration of the results of the meeting held 2 days before the AHWP meeting.

The meeting begun by presenting the WG 's mission that was to commit to carry out the results of the activities of expert group consisted of the 25 leaders and members. The 3 TC members and 3 AHWP Secretariat stuffs were supporting the activities. (For more detailed information, please refer to http://www.ahwp.info).

• WG1 (Pre-Market Submission and CSDT)
• WG2 (PMS and Vigilance)
• WG3 (QMS)
• WG4 (Quality System Audit)
• WG5 (Clinical Evidence Requirement)
• WG6 (Capacity Building and Regulatory Training)
• Special Task Group (MD-Nomenclature)

3.4 Cooperation with the APEC

• Correspondence to AHWP of International Medical Devices Regulatory Harmonization Training by the APEC fund.
  Jeffery Gren (US Department of Commerce)
  Although the education costs much, the Regulators education in the GHTF guidance documents, yet irregularly, has been held from March 1999 on occasion of any international meeting under the auspice of the APEC. The goal of this education is to help the regulators in understanding of the guidance documents prepared by the GHTF SG. As a result, ASEAN countries tend to adopt the STED(Summary Technical Document) or ISO13485. Some countries have revised the existing regulatory or adopted or intend to adopt the new regulatory regime based on GHTF principles. These countries are: Malaysia, Singapore, Hong Kong and other ASEAN countries.
  
  
• APEC Life Science Innovation Forum
  Mike Ward (Health Canada)
  Since the APEC LSIC deals with policy, international standards and international harmonization, as a result it has established the ICH international cooperation group which is getting excellent results. In the education subjects, GHTF guidance documents are included of course. The APEC Harmonization Center (AHC) and the Regulatory Harmonization Steering Committee (RHSC) were established and have begun their activities. The Japanese Industry has sent the chairman of the JIRA International Division to the RHSC as a learned man in Regulations to have been a member. As there are several regulatory harmonization groups, the APEC LSI works with each organization of them avoiding any redundant activity.

4. Information (Participant members)

The countries of more than 5 member participants were as follows: Hong Kong: 80, People 's Republic of China: 77, USA: 38, Singapore: 37, Taiwan: 28, Korea: 20, Australia: 11, India: 10, Malaysia: 9, Thailand: 8. Japanese participants were 1 of administration, 1 of the third organization and 2 of JIRA members from the industry, for information.