Study offers security measures for safeguarding brain implants

Brain-computer interfaces (BCIs)—implantable medical devices used to treat neurological conditions—are becoming increasingly sophisticated, making them more vulnerable to cyberattacks.

In a new study, researchers with Yale’s Digital Ethics Center (DEC) recommend measures that BCI manufacturers and government regulators can adopt to protect patients’ safety and privacy. Among their recommendations, the researchers advise regulators to mandate non-surgical methods for updating and recovering devices, strong authentication schemes for BCI software modifications, and the encryption of data moving to and from patients’ brains.

“BCIs are an exciting new frontier in personalized medicine that can vastly improve patients’ quality of life, but without strong security measures, cyberthreats can put their health and privacy at serious risk,” said lead author Tyler Schroder, a 2025 Yale graduate who worked on the study while a research fellow at the DEC.

“Manufacturers and regulators need to get this right. To help them, we’ve identified several areas of vulnerability and suggest a menu of options to enhance the cybersecurity of BCIs.”

For the study, which was published recently in the journal Neuroethics, the researchers designed a hypothetical threat model to identify potential cybersecurity risks to BCI patients and assess the likeliness of each type of hazard.

BCIs offer patients several significant therapeutic benefits. They can be used to prevent seizures, enhance motor control for patients with Parkinson’s disease or other neurological conditions, and relieve treatment-resistant mental illnesses through deep-brain stimulation.

When they were first developed, BCIs were single-purpose devices that performed one health function on a continuous loop. Today, BCIs are becoming more like personal computers with features that include post-implantation software updates, local data storage, and real-time data transmission to external devices, according to the study.

BCIs are considered Class III implantable medical devices under U.S. law, subjecting them to the most stringent regulations. (Other Class III devices include pacemakers and cochlear implants.) However, regulations in the United States and abroad have struggled to keep pace with technological innovation, such as the latest BCIs, which are networked devices that can be accessed and updated remotely, the researchers explained.

“The latest BCIs inhabit a liminal space where, as medical implants, they are subjected to tight hardware restrictions, but their onboard software is loosely regulated,” said Schroder, who earned bachelor’s and master’s degrees in computer science while a Yale undergraduate. “It is important to strengthen security measures before the next generation of BCIs become available.”

Absent effective guardrails, a widespread security breach in standardized BCI systems could affect millions of users simultaneously, leading to mass manipulation of neural data or the impairment of cognitive functions of those with BCI implants, the researchers said.

Such an attack “could paralyze critical infrastructure by incapacitating key personnel, disrupt social order through mass disorientation, or even enable hostile actors to harvest sensitive thoughts and memories across an entire population,” the study found.

Through their threat analysis, the researchers identified four key problem areas: software updates; authentication and authorization for wireless connections; minimizing opportunities for wireless attacks; and encryption.

Non-surgical software updates allow clinicians to quickly adjust a patient’s BCI to improve performance or resolve vulnerabilities without needing to perform a complicated surgical procedure, the researchers said. They recommend that manufacturers and regulators ensure that all software updates have integrity checks to guard against bad or malicious updates and an automated recovery plan if updates fail.

The researchers recommend strong authentication and authorization schemes for accessing BCI settings or data.

“Many older medical devices, including older BCIs, assume that if you can connect to them, you must be allowed to make changes,” Schroder said. “We call for login schemes to make sure that only clinicians and patients are able to access BCIs and edit their settings.”

Constant connections to wireless networks, however, expose BCIs to cyberattacks. To reduce opportunities for attacks, the researchers suggest that regulators require manufacturers to implement a feature that allows patients to enable or disable wireless connections to their BCIs, which only require a connection when transferring data or updating settings.

Most leading-edge BCIs lack encryption due to power limitations of the devices, the researchers noted. However, the U.S. Food and Drug Administration requires all health data be encrypted to protect against theft and privacy breaches. The researchers recommend that regulators only require encryption of BCI data when it is being transferred to and from the device and a remote computer, which would minimize demands on power.

The researchers also recommend steps to guard BCIs against the malicious use of artificial intelligence (AI).

“AI in personalized medicine like BCIs has both benefits and risks,” Schroder said. “As shown by other researchers, it’s possible to use AI to send malicious stimuli to a patient’s implant and cause unwanted BCI action. We recommend training AI against making such attacks and allowing patients to limit what actions the BCI can take limit opportunities for AI to negatively influence them.”

Brain-computer interfaces (BCIs)—implantable medical devices used to treat neurological conditions—are becoming increasingly sophisticated, making them more vulnerable to cyberattacks.

In a new study, researchers with Yale’s Digital Ethics Center (DEC) recommend measures that BCI manufacturers and government regulators can adopt to protect patients’ safety and privacy. Among their recommendations, the researchers advise regulators to mandate non-surgical methods for updating and recovering devices, strong authentication schemes for BCI software modifications, and the encryption of data moving to and from patients’ brains.

“BCIs are an exciting new frontier in personalized medicine that can vastly improve patients’ quality of life, but without strong security measures, cyberthreats can put their health and privacy at serious risk,” said lead author Tyler Schroder, a 2025 Yale graduate who worked on the study while a research fellow at the DEC.

“Manufacturers and regulators need to get this right. To help them, we’ve identified several areas of vulnerability and suggest a menu of options to enhance the cybersecurity of BCIs.”

For the study, which was published recently in the journal Neuroethics, the researchers designed a hypothetical threat model to identify potential cybersecurity risks to BCI patients and assess the likeliness of each type of hazard.

BCIs offer patients several significant therapeutic benefits. They can be used to prevent seizures, enhance motor control for patients with Parkinson’s disease or other neurological conditions, and relieve treatment-resistant mental illnesses through deep-brain stimulation.

When they were first developed, BCIs were single-purpose devices that performed one health function on a continuous loop. Today, BCIs are becoming more like personal computers with features that include post-implantation software updates, local data storage, and real-time data transmission to external devices, according to the study.

BCIs are considered Class III implantable medical devices under U.S. law, subjecting them to the most stringent regulations. (Other Class III devices include pacemakers and cochlear implants.) However, regulations in the United States and abroad have struggled to keep pace with technological innovation, such as the latest BCIs, which are networked devices that can be accessed and updated remotely, the researchers explained.

“The latest BCIs inhabit a liminal space where, as medical implants, they are subjected to tight hardware restrictions, but their onboard software is loosely regulated,” said Schroder, who earned bachelor’s and master’s degrees in computer science while a Yale undergraduate. “It is important to strengthen security measures before the next generation of BCIs become available.”

Absent effective guardrails, a widespread security breach in standardized BCI systems could affect millions of users simultaneously, leading to mass manipulation of neural data or the impairment of cognitive functions of those with BCI implants, the researchers said.

Such an attack “could paralyze critical infrastructure by incapacitating key personnel, disrupt social order through mass disorientation, or even enable hostile actors to harvest sensitive thoughts and memories across an entire population,” the study found.

Through their threat analysis, the researchers identified four key problem areas: software updates; authentication and authorization for wireless connections; minimizing opportunities for wireless attacks; and encryption.

Non-surgical software updates allow clinicians to quickly adjust a patient’s BCI to improve performance or resolve vulnerabilities without needing to perform a complicated surgical procedure, the researchers said. They recommend that manufacturers and regulators ensure that all software updates have integrity checks to guard against bad or malicious updates and an automated recovery plan if updates fail.

The researchers recommend strong authentication and authorization schemes for accessing BCI settings or data.

“Many older medical devices, including older BCIs, assume that if you can connect to them, you must be allowed to make changes,” Schroder said. “We call for login schemes to make sure that only clinicians and patients are able to access BCIs and edit their settings.”

Constant connections to wireless networks, however, expose BCIs to cyberattacks. To reduce opportunities for attacks, the researchers suggest that regulators require manufacturers to implement a feature that allows patients to enable or disable wireless connections to their BCIs, which only require a connection when transferring data or updating settings.

Most leading-edge BCIs lack encryption due to power limitations of the devices, the researchers noted. However, the U.S. Food and Drug Administration requires all health data be encrypted to protect against theft and privacy breaches. The researchers recommend that regulators only require encryption of BCI data when it is being transferred to and from the device and a remote computer, which would minimize demands on power.

The researchers also recommend steps to guard BCIs against the malicious use of artificial intelligence (AI).

“AI in personalized medicine like BCIs has both benefits and risks,” Schroder said. “As shown by other researchers, it’s possible to use AI to send malicious stimuli to a patient’s implant and cause unwanted BCI action. We recommend training AI against making such attacks and allowing patients to limit what actions the BCI can take limit opportunities for AI to negatively influence them.”