Bioethics Committee

There has been some activity on the ethics front. The Pain Section had already started gathering a group to look at the many ethical issues involved with various devices, including ones that most of us use. Many of the members of this group are also members of our society. Erika Petersen has been instrumental in getting things started and Jason Schwalb and Josh Rosenow have also been instrumental in the effort. We have also recruited, among others, Paul Ford, a bioethicist and director of the Center for Bioethics at the Cleveland Clinic and Barbara Evans, a Law Professor specializing in biomedical engineering and ethics at the University of Houston. Together, this working group is looking to address the following issues and their ethical implications:

Devices and Benefits of Collecting Patient Data

  • SCS
    • Accelerometer data
    • ECAPs data
    • Imaging data
    • Historic programming and usage information
  • RNS
    • ECoG/EEG continuous recording
  • DBS
    • Accelerometer
    • LFP and other neural activity
    • Programming and usage information
  • IT pumps
    • Medications, dose, refill timing
  • All devices – patient contact info, demographics
  • Future options

Means of Data Storage

  • Local on device and unlinked programmers (tablets, dedicated computer or programmer, proprietary or commercially available protocols for connections)
  • Device manufacturer server
  • Cloud services from third parties (Box, Dropbox, Cranial Cloud and other research sites, etc)
  • Other devices with storage (rep programmers, rep and physician personal tablets and phones)

Types of Data Collected

  • Accelerometer
  • Neural recording (EEG, LFP, ECAP etc)
  • Patient demographics, soc sec #
  • Patient programming data, device usage data
  • Patient images and correspondence
  • Patient health insurance information

Potential Risks and Concerns

  • Data security
  • Patient privacy, HIPAA and beyond
  • “Misuse” or derivative use of data (e.g. use for worker’s comp evaluations and coverage, criminal evidence, other legal proceedings – adultery, etc., nefarious/malicious alterations in device settings, loss of local control of device)

Legal Protections (and Gaps) in the U.S.: Due Process, Self-incrimination and Search and Seizure

  • 4th amendment
  • 5th amendment
  • 14th amendment
  • International perspective on legal protections

Ethical Considerations

  • Informed consent for patients
    • What data are collected
    • How weak privacy protections actually are
  • Who owns the data (Should be the patient, but how is this controlled if it’s held by the device manufacturer)
  • How can data be used, shared or analyzed
  • How long can data be stored, accessed and used
  • Rights for patients to restrict data collection, use and request deletion
    • Should opt in be default
    • Can patients select which data to share and which to conceal

Measures Currently in Place within Industry to Protect Privacy

  • Controller and device security (cybersecurity/ hacker prevention)
  • Data privacy and breach prevention
  • Patient and clinician education about data use benefits and possible risks
  • Survey of major industry players to determine current status of measures to prevent device hacking, methods of patient data storage (box, M-star, etc.) and prevention of data breach, modes of data protection

Measures to Protect Device Security

  • Methods of interacting with devices – bluetooth, RF, etc.
  • Possibility of device hacking by malicious actors and methods of prevention

Recommendations

  • Code of Ethics–principles voluntarily agreed to by device manufacturers and published widely, such as included in patient handbooks, digital sites and device identification cards
  • Updated US federal legislation to address privacy gaps not covered by current law
  • Program of public awareness
  • Possible Recommendation for standardized data collection opt-in form for patients

Summary

  • One of the main bioethics areas being explored: medical devices can collect human data and the patients do not have full knowledge or control of what happens with that data.
  • Drs. Gross, McInerney and Sheth will reach out to NIH to explore a possible bioethics collaboration.