Data  Policy  for  Internet  of  Things  Healthcare  Devices:

May  6,  2016

Marcus  ComiterHarvard  University

Aligning  Patient,  Industry,  and  Privacy  Goals  in  the  Age  of  Big  Data

Digital

Physical

Sense

Internet  of  Things  (IoT)

Network

Take  Actions

Components  of  an  IoT Healthcare  System

Data  Layer

Devices

Applications

Types  of  Healthcare  Data

Electronic  Health  Records

New data modalities:activity and sleeptrackers, daily bloodchemistry analyzers,24/7 heart ratemonitors

Internet  of  Things

Digital version ofexisting datamodalities

Ramifications  of  the  Healthcare  IoT and  Data  Layer

• Fundamentally  transform  aspects  of  chronic  disease  prevention  and  treatment

• Medical  Research• Long-­‐term  collection• Large-­‐scale  studies• New  modalities

• New  economic  models• Provision  of  immediate  incentives  for  healthy  living  via  market  forces

Potential  Futures

Innovation  and  Advancement

Misuse  and  Abuse Nothing  at  All

>

Main  Points

Comparative  Approach:  Looking  to  the  Internet  as  a  Model

The  data  collected  from  IoT healthcare  devices  is  fundamentally  different  in  nature  from  traditional  sources  of  healthcare  data,  such  as  medical  records,  and  far  more  similar  to  data  characterized  by  the  development  of  the  Internet.  

> Third  Party  Data  Auditors  (TPDAs)  as  a  Solution

TPDAs  are  specialized,  highly  technical  third  party  actors  hired  by  individuals  to  audit  the  use  of  their  healthcare  data  by  data  owners  such  as  insurance  companies,  data  brokers,  and  researchers.  TPDAs  address  the  shortcomings  of  the  data  policy  regulation  on  the  Internet  by  building  in  both  a  technical  and  policy  regime  to  the  Healthcare  IoT and  Data  Layer  itself  that  is  aimed  at  explicitly  aligning  the  incentives  of  patients,  researchers,  insurers,  and  government  with  the  end  goal  of  treating  and  preventing  chronic  disease  while  giving  users  full  control  over  and  understanding  of  their  data.  

Outline  of  Talk

1. Considerations  in  Designing  Policy  for  Data  as  a  Healthcare  Platform  

1. Third  Party  Data  Auditors:  A  New  Solution

2. TPDAs  Address   Important  Considerations   in  Data  Policy

1. Policy  Recommendations  for  Precipitating  TPDAs

Policy  Considerations

Consideration  One

Individual  Awareness

Individual  Awareness

• The  ability  of  individuals  to  be  cognizant  of  what  data  has  been  collected,  and  how  it  could  possibly  be  used.

• Even  when  privacy  may  not  exist,  an  awareness  of  this  lack  of  privacy  has  utility

Individual  Awareness  on  the  Internet

• The  current  model  of  data  collection  on  the  Internet  greatly  complicates,  if  not  destroys,  the  concept  of  individual  awareness.

• Structurally,  the  Internet  has  developed   into  a  de  facto  surveillance  state.  

• The  data  collection  happens  surreptitiously:  technology  facilitates  tremendous  amounts  of  data  collection  without  ever  needing  to  inform  or  interact  with  its  target• Incidental• Purposeful• Systematic

• Data  brokers

Individual  Awareness  in  the  Healthcare  IoT

• The  same  challenges  to  consumer  awareness  discussed  in  the  previous  section,  as  well  as  additional  ones,   apply  just  as  strongly  to  the  Healthcare  IoT and  Data  Layer

• Lack  of  consent  mechanism  for  IoT devices   (Activity  Tracker  example)

• Phone  as  the  core  of  a  Personal  Area  Net  (PAN)

Consideration   Two

Accountability  through  Transparency

Accountability

• Accountability  of  actions  taken  on  the  data  layer  rely  on  transparency  of  practices

• This  lack  of  accountability  is  strikingly  out  of  line  with  existing  policy  in  similar  matters

• The  FCRA  attached  accountability  to  these  organizations  by  requiring  them  to  “provide  notice  when  an  adverse  action,  such  as  the  denial  of  credit,  is  taken  based  on  the  content  of  [their]   report.”

• Realize  the  relevancy  of  this  legislation  to  the  current  situation  of  the  data  layer:  a  non-­‐consumer  facing  industry  (credit  agencies)  that  had  substantial  powers  over  consumers  (the  public)  but  little  accountability,  was  legislatively  mandated  to  increase  its  accountability  to  consumers.  

• This  situation  mirrors  the  data  layer,  and  bears  special  resemblance  to  data  brokers.  

Accountability  on  the  Internet

• Many  data  layer  firms  are  not  consumer-­‐facing   firms  (i.e.,   the  firms  collecting,  selling,  and  using  the  data  of  a  particular  individual  do  not  necessarily  have  a  relationship  with  that  individual)• E.g.,  data  brokers  have  virtually  no  relationship  with  subjects

• Many  individuals  are  completely  unaware  even  of  the  existence  of  data  brokers,  let  alone  do  they  understand  how  their  data  is  being  used.  

Accountability  in  the  Healthcare  IoT

• Just  as  in  the  Internet  economy,  data  brokers  have  already  emerged  combining  and  selling  anonymized healthcare  data.

• As  individuals  and  their  medical  care  will  be  increasingly  affected  by  the  data  associated  with  them,  they  have  a  fundamental  right  to  ensure  attributes  such  as  the  accuracy,  collection  standards,  and  use  of  this  data  are  appropriately  held  to  societal  standards.

• These   ideas  are  certainly  not  novel:  they  have  underscored  the  FTC’s  Fair  Information  Practice  Principles  (FIPPs)  since  the  1970s.  

Consideration   Three

Enforcement  of  Existing  Laws

Enforcement  on  the  Internet

• Data  points,  when  combined  and  used  with  inference  algorithms,  can  be  used  to  create  de  facto  indicators  of  race,  ethnicity,  religion,  sexual  orientation,  and  other  markers  that  have  traditionally  been  avenues   for  discrimination

• A  White  House  report  on  Big  Data  cites  an  instance  of  racial  discrimination  on  the  Internet  (search   result  example)

Enforcement  on  the  Healthcare  IoT

• Firms  may  hide  behind  complicated  algorithms  that  are  able  to  create  discriminatory  or  harmful  behavior  automatically.

• This  firm  may  create  an  algorithm  which,  when  given  data  as  input,  automatically  learns  discriminatory  behavior.• Many  ethnic,  religious,  and  racial  groups  have  particular  health  

issues  that  can  be  traced  not  only  to  genetic  causes,  but  also  to  cultural  and  societal  causes.  Algorithms  may  potentially  create  de  facto  indicators  for  these  lawfully  protected  groups  

• This  can  even  happen  without  the  knowledge  of  the  firm  itself

Consideration   Four

Protecting  Innovation

Protecting  Innovation

• Previously  discussed  advancements

• Maintaining  consumer  confidence  in  the  Healthcare  IoT and  Data  Layer  itself

• With  the  power  the  data  provides  firms,  there  are  a  number  of  incentives  for  firms  with  access  to  this  data  to  act  poorly  in  order  to  turn  a  quick  profit

Third  Party  Data  Auditors  (TPDAs)

What  are  TPDAs?

• TPDAs  are  a  class  of  highly  technical,  skilled,  private  market  organizations  that  are  hired  by  individuals  to  monitor  and  audit  the  collection  and  use  of  their  data.  

• After  collecting  all  of  the  data  that  has  been  collected  on  their  clients  by  data  layer  firms,  TPDAs  analyze  the  data  that  was  collected,  how  the  data  was  collected,  and  how  it  was  used.  

• Once  finished  with  this  analysis,  the  TPDAs  present   their  findings  to  the  client  in  an  easy  to  comprehend  report,  as  well  as  alerting  them  to  potentially  harmful,  unscrupulous,  or  unlawful  collections  or  uses  of  data.  

• By  empowering  individuals,  TPDAs  will  allow  the  citizenry  to  regain  control  of  their  lives  on  the  data  layer.  

What  are  TPDAs?

• TPDAs  are  entirely  devoted  to  protecting  the  citizenry  on  the  healthcare  data  layer• A regulatory  policy  creating  TPDAs  are  essentially  instantiating  a  

permanent  citizen  advocate  in  the  data  layer.  

• TPDAs  will  embody  policy  goals  without  top  down  regulation

• TPDAs  market-­‐based   structure  allows  them  to  address   the  rapidly  changing  technology  sector

• TPDAs  can  address  data  layer  regulation  by  leveraging  the  same  entrepreneurial   spirit,  energy,  and  zeal  that  has  itself  created  the  technology  sector  (fighting  fire  with  fire)

How  TPDAs  will  Operate

1.  Certification

• Similar  structure  to  other  trusted  groups

• Doctors

• Lawyers

• Credit  Reporting  Agencies

2.    Initial  TPDA  Setup

• Choose  which  data  layer  firms  (i.e.  which  data  brokers,  for  example)  the  TPDA  will  offer  as  part  of  its  auditing  services

• Write  software  to  be  able  to  interact  with  these   firms’  data  systems,  allowing  the  TPDA  to  work  with  the  data  it  receives  on  its  clients  from  the  data  layer  firms.

• Begin  creating  the  software  they  will  use  to  analyze  and  audit  their  clients’  data.  • Using  highly  technical  data  processing,  machine  learning,  and  

statistical  techniques,  each  TPDA  will  design  its  own  “secret  sauce”  with  which  to  understand  how  data  is  used.  

3.    Client  Hires

• The  client  provides  the  appropriate  level  of  identification,  as  well  as  authorization  to  request   their  data  from  data  layer  firms.  

4.    TPDA  Requests  Data

• TPDA  uses  the  identification  and  authorization  provided  by  its  client  to  pull,  or  request,  the  client’s  data  from  all  data  layer  firms  with  which  the  TPDA  offers  auditing  services.  

5.  The  TPDA  Parses  and  Analyzes  the  Data    

• Using  the  proprietary  algorithms  and  methods  it  has  previously  designed,  the  TPDA  begins  analyzing  how  the  client’s  data  has  been  used.  

• By  searching  for  common  patterns,  understanding  use  cases,  and  tracking  data  flow  between  all  of  the  firms  being  audited,  the  TPDA  attempts  to  find  all  of  the  relevant  information  regarding  the  use  of  the  data.

• This  is  a  very  powerful  idea,  as  TPDAs  directly  allow  technology,  rather  than  just  policy,  to  regulate  the  data  layer.  

6.    Formulating  a  Report

• The  TPDA  produces  a  detailed  report  for  each  of  its  clients that  is  both  informative  and  actionable

• Each  report  contains  information  regarding  how  the  client’s  data  has  been  used,  and  will  alert  clients  to  any  potential  sensitive,   illegal,  or  abusive  uses  of  data.  

• This  report  may  also  make  suggestions  as  to  changes  in  use  of  technologies,  tracking  opt-­‐out  opportunities  not  currently  utilized,  and  other  potential  suggestions  of  import.  

How  TPDAs  Address  Policy  Considerations

Individual  Awareness

• The  cornerstone  of  TPDAs  is  in  providing  individual  awareness  as  a  service

• Through  the  report  and  advisory  roles  TPDAs  play,  consumers  are  empowered  to  understand  what  data  has  and  is  being  collected,  and  how  this  data  is  being  used,  shared,  and  sold  within  the  data  layer

Accountability  through  Transparency

• TPDAs  create  an  accountability  mechanism  by  creating  a  window  through  which  consumers  may  examine  data  layer  firms.

• Importantly,  this  window  is  a  meaningful  one  through  which  consumers  may  draw  useful  and  actionable  information,  and  is  well  suited  to  the  current  and  future  state  of  the  data  layer.

Enforcement  of  Laws

• On  an  individual  level,  consumers  can  now  see  what  information  has  been  collected  and  shared  with  particular  organizations,  as  well  as  the  data  based  inferences  made  from  it  by  data  layer  firms  such  as  data  brokers.  

• Once  empowered  with  this  information,  consumers,  either  by  their  own  impetus  or  on  recommendation  of  their  TPDA,  may  further  examine  potential  misuses  of  data.  

Protecting  Innovation

• Realize  that  there  is  little  if  any  burden  placed  on  data  layer  firms

• Rather  than  recommending  top  down,  broad  regulatory  policy  for  the  data  industry  as  a  whole,  TPDAs  empower  better  decision  making  through  empowering  consumers  and  regulators  to  better  understand  the  data  industry  and  how  it  operates.  

1. Mandate  Data  Access

2. Create  TPDA  Regulations  and  Certification  Process

3. Educate  the  Citizenry

Policy  Recommendations

Congress should mandate that all Healthcare IoT andData Layer firms must oblige consumer requests foraccess to any data held on them by a firm, regardless ifthat firm collected or purchased that data. Data includesboth facts directly collected on an individual, as well asinferences made about that individual.

Mandate  Data  Access

Congress should create a task force to create thenecessary regulations regarding the legal responsibilitiesof TPDAs, or task the FTC with this responsibility.Following this, Congress should task the FTC with settingup the mechanism to create the TPDA certificationprocess.

Create  TPDA  Regulations  and  Certification  Process

Congress  should  create  a  task  force  to  educate  the  citizenry  regarding  the  existence  of  TPDAs  and  the  services  they  offer.

Educate  the  Citizenry

Given  the  means,  knowledge,  and  ability  to  exercise  meaningful  control  over  their  digital  lives,  citizens  will  be  able  to  make  the  most  of  the  great  opportunities  the  Healthcare  IoT presents.

Closing  thought

Thank  You