Chapter 201 Safety Standards
Chapter 201 Safety Standards
Before the online criticism had completely subsided, the invitation from the National Health Commission arrived.
The invitation was formally worded, stating that a seminar on the safety of clinical applications of brain-computer interfaces was to be held, and that 402 Technology, as a core technology unit, was invited to attend and give a technical presentation. The date on the letter was four days after the ethics press conference.
Han Lu printed out the invitation and placed it on Zuo Cheng's desk. She said, "This is a good thing. The government's initiative to extend an invitation shows they are seriously considering proceeding."
Zuo Cheng glanced through the list and asked, "Who are the other participating organizations?"
Han Lu said, "The Neurosurgical Society, the State Administration of Medical Devices, Tsinghua University, Peking University School of Medicine, and two international medical institutions."
Zuo Cheng said, "This is a review, not a report. They want to see if 402's security system is robust enough."
Han Lu said, "Then how should we prepare?"
Zuo Cheng said, "We need to compile our security system into a white paper, a comprehensive one, leaving no loopholes."
He opened the technology tree panel and silently checked the status of the eighth branch in his mind. Three leaves had already grown in the direction of brain-computer interfaces. The two nodes of commercial application and technical standards had not yet been reached, but the accumulation of technology was accelerating.
System notification: The current accumulation rate of the eighth branch is 43%. The industry standard node is expected to be activated after the release of the technical white paper.
Zuo Cheng closed the panel; the significance of this matter was greater than he had imagined.
Over the next five days, Zuo Cheng, along with Shen Yiming, Professor Zheng, and Tang Ning, thoroughly reviewed the security system of 402. The final document they compiled was called the "White Paper on Standards for the Secure Application of Brain-Computer Interfaces," totaling forty-seven pages and divided into four chapters.
Chapter 1, Hardware Security. The NX-30 chip's material selection, implantation standards, self-testing mechanisms, and fault-breaking procedures are detailed, each accompanied by actual data from Zhang Wei's surgery. The chip incorporates a built-in safety redundancy design, automatically disconnecting from external devices in the event of signal abnormalities, with a response time of less than twenty milliseconds.
Chapter Two: Surgical Safety. From preoperative imaging assessment to postoperative infection monitoring, a complete standardized surgical procedure is provided, along with normal ranges for 12 key indicators and emergency response plans.
Chapter 3, Data Security. This chapter covers the technical principles of the federated learning framework, the scope of neural signal acquisition, local data storage encryption mechanisms, and the technical guarantees against accessing raw data via the 402 Not Accessible test. This is the thickest chapter because data privacy is the area of greatest public concern.
Chapter Four, Ethical Safety. This chapter covers the specific procedures for informed consent, the patient's right to request device removal at any time, and plans for establishing industry ethics committees.
The night the white paper was completed, Zuo Cheng sent the document to Li Mingyang for a review.
Li Mingyang replied, "Very comprehensive, but the last page of Chapter 3 could be more specific, explaining at which stage federated learning ensures that data does not leave the local machine."
Li Mingyang then sent a technical description, a phrase previously used in a paper by Star Technology. Zuo Cheng added it in, polished it, and made the logic clearer.
The seminar was scheduled for a Thursday morning in the conference room of the Health Commission. Zuo Cheng took Shen Yiming and Professor Zheng with him; Shen Yiming carried his notebook, and Professor Zheng carried the printed manuscript.
There were already more than twenty people seated in the conference room. Experts from the Neurosurgical Society, officials from regulatory bureaus, university professors, and representatives from various fields were present. Seated at the head of the table was the Director of the Science and Technology Department of the National Health Commission, a man in his fifties surnamed Wu, who appeared very composed.
As soon as Zuo Cheng entered, he sensed an atmosphere of scrutiny in the conference room. This was not a meeting of supporters, but a meeting of reviewers.
Director Wu said, "Thank you to 402 Technology for attending. Today's seminar mainly discusses the safety issues of clinical applications of brain-computer interfaces. Please share your professional opinions. Mr. Zuo Cheng, please give a technical presentation first."
Zuo Cheng said, "Okay." Instead of opening the PowerPoint presentation, he distributed a printed copy of the white paper to each participant, then stood up and spent fifteen minutes explaining the core content of the four chapters.
After he finished speaking, there was a few seconds of silence in the conference room.
The first question came from a section chief at the regulatory bureau. He asked, "The white paper says the chip has a fault-breaking mechanism. If the connection is suddenly lost while the patient is using the exoskeleton to walk, could it cause a fall?"
Zuo Cheng said, "This is a scenario we considered. There is an independent posture-maintaining module between the exoskeleton system and the chip. When the signal is interrupted, the exoskeleton automatically switches to support mode and the joints lock to prevent the patient from falling. We conducted 400 simulated disconnection tests in the lab, and not a single fall occurred."
The section chief made a mark on the white paper and did not ask any further questions.
An expert from the Neurosurgical Society asked, "Regarding your surgical standards, have the prescribed implantation depth and location been validated through large-scale clinical trials, or are they based on only a single case?"
Shen Yiming spoke up, saying, "Currently, there is only one clinical case, but the implantation parameters were based on publicly available data from 37 related surgeries internationally, and adjustments were made to suit the specific dimensions of the NX-30 chip. The parameter ranges in the white paper are conservative values, not extreme values."
The expert nodded and said, "Being conservative is the right thing to do."
The most pointed question came from a university professor: "Regarding data security, you promise not to access raw neural signal data. But where is the aggregation server for the federated learning framework, and who guarantees that there will be no data leakage during the aggregation process?"
Zuo Cheng glanced at him and said, "That's a good question. The aggregation server is deployed in the local data center (402), with no external access interface. The aggregation process in federated learning only transmits the gradients of the model parameters, not the raw data. If you have any concerns, we can offer third-party audits of the technical architecture."
The professor said, "Third-party audits should be done."
Zuo Cheng said, "Agreed. We are willing to accept a technical audit by a nationally designated third-party organization, including chip design, data flow, and surgical standards, all of which will be open for review."
The atmosphere in the meeting room changed slightly, and the scrutinizing tone lessened.
Director Wu said, "Today's report was very comprehensive. We will carefully study the contents of the white paper, and an expert review committee will conduct an evaluation later. The third-party audit plan proposed by 402 Technology is a positive statement."
After the seminar, several experts exchanged business cards with Zuo Cheng in the corridor. The expert from the Neurosurgical Society said, "Your safety framework approach is correct. Once the audit results are available, I personally support its implementation."
Zuo Cheng said, "Thank you. We'll wait for the audit."
On the way back, Shen Yiming said, "I think the response today was better than expected."
Zuo Cheng said, "Don't be too happy yet; the audit is the real hurdle."
Professor Zheng said, "But they didn't ask any questions we couldn't answer, which shows that the white paper is well-made."
Zuo Cheng said, "The white paper is the first step. The next step is to translate each standard into verifiable processes and data. Promises must be able to withstand scrutiny."
He leaned against the car window, looking out at the city of Hangzhou.
This white paper was compiled by him over five days. But behind every standard in it are the two hours Zhang Wei spent in surgery, two weeks of signal calibration, and ten days of exoskeleton integration.
Safety standards are not written out of thin air; they are extracted from real-world cases.
This is what 402 can provide to the industry, and it is also what the industry needs.
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