Risks Related to Laws, Regulations and Approvals in the AI Solutions Business
First written in FY2019. 2 of 5 entries say "Restated". Latest entry: FY2026.
Fronteo moved to the "Worse" side of this theme in 2026, 1 year after the typical company in this theme (2025).
The whole theme swung hardest in 2024: 1 of 6 companies on the "Worse" side.
2 other companies' latest entry also says "Reframed".
- FY2026ReframedAnnual report
「In Japan and overseas, the development and implementation of AI-related laws, guidelines for AI businesses and other AI-related systems and guidelines are progressing. In addition to establishing systems to address the development, provision and use of AI, transparency, accountability, safety and data management, the Company may also be required to comply with existing laws and regulations, including the Act on the Protection of Personal Information, the Copyright Act and the Unfair Competition Prevention Act.」
The risk profile broadened from the traditional life sciences AI risks centered on pharmaceutical and medical device regulations to company-wide regulatory compliance risks covering AI-related laws and guidelines, transparency, accountability, data management and copyright, among other areas. - FY2024-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
No material changes were identified in the regulatory and licensing risks facing the AI solutions business. - FY2022-Q2MitigatedAnnual report
「On 7 September 2021, the company filed a notification with the Tokyo Metropolitan Government to engage in the sale of controlled medical devices, and the notification was accepted. In January 2021, FRONTEO had already obtained a license from the Tokyo Metropolitan Government to market manufactured Class I medical devices. This notification enables FRONTEO to distribute and sell medical devices it developed in-house directly to medical institutions and other customers.」
In response to risks related to medical device laws, regulations and licensing, notification of the sale of managed medical devices was accepted following the acquisition of a Class I medical device marketing license, establishing an in-house distribution and sales structure. - FY2021RestatedAnnual report
「In connection with the AI solutions business, the life sciences AI field must comply with the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.」
The company continued to disclose compliance with laws and regulations concerning pharmaceuticals and medical devices in life sciences AI, together with the risk of revising plans and increasing expenditures following the enactment of future regulations. - FY2019First statedAnnual report
「At present, the AI solutions business must comply in the healthcare field with the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. If new laws or regulations are enacted in other fields, or if industry self-regulation is required, it may become necessary to revise the Group's business plans and other measures.」
The company explicitly identified as risks compliance with laws and regulations concerning pharmaceuticals and medical devices in the healthcare field, as well as revisions to plans and higher expenditures resulting from future laws, regulations and self-regulation.