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Once Your Device Acquire & Provide Patient Information, It's Already Inside of Hospital's Policy of Protection. How Would You Adopt ?
Recent dramatic IT progress in AI, Machine Learning, etc. are expediting revolutionary medicine and medical devices. Of course, the competition is getting severer.
Especially many of recent medical devices are using outside data, storage means Cloud systems and your customers may hesitate to introduce and connect to hospital network. To proof your products' safety and compliance to each country's regulation, it may be necessary to introduce out side resources to fasten your business. GDPR, HIPAA, Japanese Privacy protection Act and Health Information Promotion of Secondary Use Act, etc ... Global Companies have to check these regulations. It's very hard, but not constant job.
We can help you in these challenging area, including standard regulatory and clinical data collection and analysis cases, with the specialty in each field and using connection with past collaborators, doctors, Medical IT specialists to keep your products met to customers, patients requirements.
Also, we started to provide comprehensive representative services for medical device companies aiming to get into Japanese market in the partnership with each field's expert. Earnest Job Link Ltd. and we, AHIL lead this efforts and take role of the front for inquiries. Please use contact sheet at our front page.
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We are providing Information Security-Related Supporting Services for Medical Corporations and Facilities, Health Insurance Associations, Health Practitioner Support Organizations and Social Welfare Providers in a policies listed below solely, or in the cooperation with the organizations of Information Security and/or of Cyber Crime Prevention Institutions we belong to. These services should be lead by our specialists who has the certifications of internal audit or upper ones.
The Services for Medical, Public Administration and Welfare Providers
- It is too difficult to equip the specialist who fully understand and completely execute the information management processes with complying to the requirement from elated laws and guidelines to medical related organizations.
- We support to build your operation procedures, documents and management processes centralizing Privacy Protection Acts and the execution guidelines, MHLW(*1) Safety Guidelines for Medical Information Systems.
The Services for Pharmaceutical, Medical Devices Manufacturers
- Adding to above laws and guidelines, considering that many of our customers may aim to expand the business internationally, we support your necessary certification acquisition and processes building for your strategies through the close engagement and tough discussion on expected levels with your team, existing systems vendors on behalf of you, with the deep understanding of HIPAA in United States, FDA regulations and GDPR in European Union.
- Please also check "1. Medical Devices Regulatory & Security Compliance".
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We design and develop the PHR infrastructure considering economically sustainable, compliance to regulation in each country and visually understandable/controllable evaluation process and information value and risks.
In this service, we will help you from one specific part to whole architectural design leveraging broad governmental/academic connections to meet your requirements.