From 2022, the investment and financing enthusiasm of the domestic medical and health industry will decrease slightly. However, the investment structure of the medical industry is facing a transformation, and investment is gradually showing a trend of globalization, and it continues to release vitality in the field of cross-border cooperation. At the same time, with the continuous advancement of centralized drug procurement and medical insurance negotiations, more and more Chinese health and life science companies have gone abroad to overseas markets in search of fertile ground for development.
However, global safety and compliance regulations are becoming stricter, and Chinese companies in the health and life sciences industry face many compliance pain points when going overseas, and internationalization exploration is not all smooth sailing. In order to resolve these pain points and problems, on April 14, 2023, Amazon Cloud Technology and its global consulting partner PwC jointly held a seminar on the development of the medical industry "Pharmaceutical Going to Sea Directly Linked to Cloud Sail", and officially released the "Pharmaceutical Going to sea, directly hanging on the cloud sail - a practical guide to compliance in the health and life science industry to go to sea, to help companies meet safety compliance requirements and accelerate business globalization.
Escort Security Compliance
Amazon Cloud Technology joins hands with PricewaterhouseCoopers to accelerate the overseas expansion of pharmaceuticals
In the digital age, health and life science companies are facing global innovation and unprecedented interconnection. Data protection and data compliance have become one of the most important compliance requirements in various countries, and they must also be faced by all international health and life science companies. and solve important problems. Laws and regulations related to health care and data security compliance, such as the General Data Protection Regulation (GDPR), GxP, HIPAA, and HITECH, have been successively introduced by countries and regions such as the European Union, the United States, Europe, Canada, and Japan, PwC Cooperating with Amazon Cloud Technology to launch a variety of innovative solutions, based on Amazon Cloud Technology's global security compliance infrastructure and network services, empowering pharmaceutical companies to go overseas safely.
From company management to technology implementation, compliance with GDPR
In the EU region, the General Data Protection Regulation (GDPR) stipulates rights including the right to know, the right to access, the right to rectify, and the right to delete (right to be forgotten), as long as the business organization processes personal data in activities within the EU ( Territory), all need to be complied with.
In order to help companies deal with the new compliance work under GDPR in a more organized and systematic manner, PwC combines the mature technology of Amazon cloud technology to help customers sort out and solve problems in business scenarios from two levels of company management and system implementation. Compliance risk.
● At the company level, PwC helps clients sort out and improve the existing structure, formulate relevant contract clauses and rectification suggestions that meet GDPR requirements, and build a complete institutional process system.
● At the level of system implementation, use the global security and compliance infrastructure of Amazon Cloud Technology to assist customers in identifying personal information collected by systems/functions of the cloud, management, and end, and continue to conduct risk and compliance through personal information impact assessment (PIA) The analysis provides a technical implementation plan.
Innovate together to create a HIPAA compliance consulting solution
HIPAA and HITECH are the most important regulations on health data management in the United States. HIPAA can protect patients' medical records and other individually identifiable health information, while HITECH has made more changes in HIPAA's original violation notification rules and enforcement rules. strict regulations.
After passing the HIPAA privacy and security assessment, PwC joined hands with Amazon Cloud Technology to create a HIPAA compliance consulting solution to sort out process control points for customers and pave the way for the subsequent implementation of the solution.
● From the perspective of corporate governance and high-level organizational structure, define a set of privacy and security structures that include clear roles and obligations, so as to facilitate the company's continuous and coordinated operations.
● From the perspective of policy and notification management, assist clients to sort out privacy policies, related notices, disclosures and guidelines, and ensure that their records are kept and applicable to existing laws and regulations.
● From the perspective of cross-border data strategy, plan cross-border data transfer strategies based on current data collection, use and sharing.
● From the perspective of data life cycle management, help to create a continuation mechanism to identify new personal data processing and usage activities, and match appropriate control points.
● From the level of personal rights processing process, help to establish effective personal consent and data subject request process, including data input, restriction, modification and accounting disclosure.
● From the perspective of information security, identify current information security protection measures and combine relevant security controls with laws and regulations.
● From the perspective of training and pre-prevention, help design and implement corresponding training processes, and establish training responsibilities and role obligations at the enterprise level.
● Finally, help customers establish corresponding process control systems and design appropriate emergency response specifications.
Three steps to protect drug data security
GxP includes a variety of compliance-related activity specifications, which refer to the regulations and guidelines applicable to life science companies or organizations in the United States that manufacture and develop food and medical products such as drugs, medical devices, and medical software applications.
PwC has an experienced project team that assesses compliance gaps in the overall quality system, designs and formulates compliance solutions, and implements a compliance governance framework to assist companies in obtaining certification and continuous improvement. Experts can assist organizations with the process design needed to address quality system compliance risks and facilitate sustainable implementation of the program. Amazon Cloud Technology is committed to becoming one of the available, more flexible and secure cloud computing environments. The services provided on the security infrastructure have a security baseline. Customers, regardless of size, can rely on Amazon Cloud Technology's strong scalability, high Reliable infrastructure and network services, fast and secure deployment of applications and data, and business innovation on the cloud.
● Through the three-step process of current situation research and gap analysis, program design and implementation, certification acquisition and continuous improvement, health and life science companies can respond to compliance standards more systematically and efficiently, and improve their own information system management level and technical capabilities.
Global Empowerment to Accelerate the Compliance of the Health and Life Science Industry Going Overseas
In addition to the laws, regulations and policy interpretations of the above countries and regions, for Japan, Canada and Singapore, which are popular countries for Chinese health and life science companies to go overseas, PwC has also worked with Amazon Cloud Technology to carefully study laws related to data security management , and provide corresponding solutions to help enterprises go to sea safely.
For a long time, Amazon Cloud Technology has maintained a close global cooperation with PricewaterhouseCoopers, relying on profound experience in the health and life science industry and global cloud technology resources to help enterprises comply with safety regulations and sail overseas. In the future, the two parties will continue to work together to provide one-stop services for more health and life science companies, help more customers flexibly respond to safety and compliance challenges, accelerate transformation and innovation, and expand global business.