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HIPAA in 2022 and Beyond
Being Ready for Compliance Today
and in the Future
Jim Sheldon-Dean
Director of Compliance Services
Lewis Creek Systems, LLC
www.lewiscreeksystems.com
June 14, 2022
1
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
Agenda
• Overview of HIPAA Regulatory Expectations
• Telemedicine and Communication during the Emergency
• Issues in Individual Access of Records under HIPAA
• HIPAA Accounting of Disclosures Changes
• Potential and Proposed Rules Changes
• HIPAA Controls and New Technologies
• Q&A
2
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
Part 1
• Overview of HIPAA Regulatory Expectations
– New Regulatory Directions
– New Proposed Changes for the HIPAA Privacy Rule
– Overdue Regulatory Action
– Court Ruling Limiting Regulations
– Rule Modifications and Guidance on the COVID-19
Pandemic
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
3
Information Blocking and HIPAA
• Information blocking a hot topic at HHS
– New rules in place to facilitate exchange of PHI
• It’s time to stop information blocking
– Do what you can to facilitate patient access of records
– Do what you can to facilitate transfer of records to other providers
when requested by a patient
• TWENTY-SEVEN settlements for not providing timely access under
HIPAA since September, 2019
– Called Information Blocking penalties by HHS
• Proposed changes to the Privacy Rule strengthen individual access
rights and codify prior guidance and court decisions
– Shorter deadlines to respond
– Easier access and transmission to other providers
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
4
Telemedicine and HIPAA
• Using HIPAA-compliant fully encrypted services under a HIPAA
Business Associate Agreement is fully compliant for
telemedicine use
– Skype for Business, Updox, VSee, Zoom for Healthcare, Doxy.me,
and Google G Suite Hangouts Meet
• Can follow the usual processes for Risk Analysis and secure
implementation, including a HIPAA BAA
• HIPAA has allowances for emergencies and life threatening
situations, even without a Pendemic
• Patients and providers LOVE Telemedicine! It will be with us
after the emergency
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
5
Telemedicine, HIPAA, and COVID-19
• HHS has issued an enforcement advisory on telemedicine during
the COVID-19 emergency: Relaxed enforcement for using services
that are non-public facing but may not meet HIPAA requirements
(such as providing a BAA)
– OK: Apple FaceTime, Facebook Messenger video chat, Google Hangouts
video, or Skype
• BUT: Do NOT use public-facing services that are not private
– Facebook Live, Twitch, TikTok, and similar
• And: Once the emergency is over you will need to use HIPAA
compliant services, under a Business Associate Agreement,
according to a HIPAA Security Risk Analysis
• See: https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-
preparedness/notification-enforcement-discretion-telehealth/index.html
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
6
HIPAA Allowances for Communication with Family and
Friends of Patients,
and to Prevent a Serious and Imminent Threat
• HIPAA has reasonable rules for communication and emergencies
built-in
• You can share information as needed with family and friends of the
patient without an Authorization; get a permission if you can but
don’t let it get in the way of good judgement!
– Share only what’s necessary for the purpose
• Sharing is permitted for Public Health purposes and in an
emergency
• If someone is about to get hurt, HIPAA gets out of the way
– The proposed changes to the HIPAA Privacy Rule soften this to
make it less dire, more reasonable to share information “in the
patient’s best interest”
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
7
Part 2
• Issues in Individual Access of Records under
HIPAA
– New Emphasis on Enforcement of Individual
Access Rules
– New Court Ruling Limiting Third-Party Access
Requests
– New Limitation of Business Associate Liability for
Compliance
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
8
Information Blocking Penalties in 2022
• March 28, 2022: #26 and 27:
– Jacob and Associates, a psychiatric medical services provider
with two office locations in California, said it would take
corrective actions and pay $28,000 to settle potential violations
of the HIPAA Privacy Rule, according to OCR, including
provisions of the right of access standard
– Dr. Donald Brockley, a solo dental practitioner in Butler,
Pennsylvania, failed to provide a patient with a copy of their
medical record, OCR alleges. Brockley requested a hearing
before an Administrative Law Judge; the litigation was resolved
before the court made a determination by a settlement
agreement in which Brockley agreed to pay $30,000 and take
corrective actions to comply with the HIPAA Privacy Rule's
right-of-access standard
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
9
Part 3
• HIPAA Accounting of Disclosures Changes
– Current Accounting of Disclosures Requirements
– Required Changes and Difficulties Implementing
Them
– Likely Regulation to be Proposed
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
10
Part 4
• Potential (and Proposed) Rules Changes
– Acknowledgement of Receipt of Notice of Privacy
Practices
– TCPA and Cell Phone Communications
– Impact of Potential Changes to Affordable Care
Act
– Getting Back to Normal After the Pandemic
Emergency
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
11
TCPA and Communicating to Cell Phones
• Telephone Consumer Protection Act of 1991 limits calls and
messages to cell phones without consent
• Limits Robo-calling (including reminder calls)
• There are Penalties for, without consent, calling a cell phone
or leaving:
– A payment related message (voice or text)
– A healthcare related message more than one minute
(voice) or 160 characters (text) long; no more than one per
day or three per week
• Includes healthcare reminders, appointment reminders,
etc.
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
12
When the COVID-19 Emergency is Lifted
• Allowances for using telemedicine and
vaccination appointment scheduling technologies
outside of a Business Associate Agreement during
the emergency will be ended
– Will need to switch to a HIPAA-compliant platform to
continue telemedicine and vaccination scheduling
• Allowances for special disclosures (such as by
business associates for public health purposes)
during the emergency will be discontinued
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
13
Part 5
• HIPAA Controls and New Technologies
– Difficulty in Managing Privacy
– Calls for HIPAA Expansions
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
14
New Technologies
• New technologies in health care every day
– Some new technologies will be very useful
– Some new technologies will be a privacy and security
nightmare
• You can’t deny new technologies
– New Technologies should be addressed head-on
– If you ignore them they don’t go away
– Encourage dialog on new technologies and find ways to
use them productively, securely
• Education addressing new technologies is essential
– Prevent improper uses
– Train in appropriate usage
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
15
Security and Enforcement
• Issues of portable devices & communications
– Where do the responsibilities lie?
• Mobile Devices in Health Care
– They’re already being used
– Stay Out In Front
– Issues with Transmitted and Stored PHI
– Office Obligations, Strategies
• Clients/Patients/Consumers and Mobile Devices
– Patient Rights
– Patient Care
– Patient Communications Policy
– Documentation
• Apps and Devices controlled by the individual and not provider-
driven are outside of HIPAA, and are under FTC scrutiny and FTC
Health Breach Notification Rules
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
16
Guidance re HIPAA and Health Apps
• Guidance addresses use of Apps by individuals, and at the request of
providers https://www.fiercehealthcare.com/tech/hhs-guidance-clarifies-hipaa-
liability-use-third-party-health-apps
• New HHS Health Apps page: https://www.hhs.gov/hipaa/for-professionals/special-
topics/health-apps/index.html
• Where are the obligations for Privacy and Security?
– If the patient requests communication to their App, the provider should ask
about the individual’s acceptance of risk for security, and proceed as
requested, no Business Associate Relationship needed
– If the provider requests the patient to use an App that is working on behalf of
the provider, the App provider is a Business Associate, so the provider must
assure security and provide insecure communications only at the request of
the individual
• New Proposed HIPAA Privacy Rule changes clarify some of these
obligations
• Also! FTC is reviewing its rules for Breach Notification and Health Apps
https://www.ftc.gov/news-events/press-releases/2020/05/ftc-seeks-comment-part-
review-health-breach-notification-rule
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
17
New Technologies and HIPAA
• HIPAA can handle new technologies for PHI
– Security Rule is very flexible, adaptable
– For instance, have you considered Alexa and Amazon Echo?
• New kinds of information, apps, devices, and various uses outside
the formal HIPAA definition of “Protected Health Information”
• New calls for protection of more kinds of patient information than
HIPAA covers
• Proposed HIPAA Privacy Rule changes would address many issues
more clearly
• Don’t be surprised if new laws and regulations result
– Expanded FTC activity
– State laws may also be in the works
– Expansion of existing state breach rules
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
18
Your to-do list…
✓ Don’t be in denial – willful neglect costs more than
compliance
✓ Keep your ears out for new rules, laws, guidance
✓ Provide individual access – don’t block information
✓ Be careful adopting new technologies
✓ Step up your Security game
✓ Make sure mobile devices are protected
✓ Document your processes for proper methods of
communications with both patients and professionals
✓ Conduct drills in audit and breach response
✓ Make corrections based on results
✓ Always have a plan for moving forward, and follow it!
19
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com
Thank you!
Learn More Here…
Any Questions?
For additional information, please contact:
Jim Sheldon-Dean
Lewis Creek Systems, LLC
www.lewiscreeksystems.com
20
© Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved
jim@lewiscreeksystems.com www.lewiscreeksystems.com

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HIPAA Changes for 2022 and Beyond - Today's and Tomorrow's HIPAA Compliance

  • 1. HIPAA in 2022 and Beyond Being Ready for Compliance Today and in the Future Jim Sheldon-Dean Director of Compliance Services Lewis Creek Systems, LLC www.lewiscreeksystems.com June 14, 2022 1 © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com
  • 2. Agenda • Overview of HIPAA Regulatory Expectations • Telemedicine and Communication during the Emergency • Issues in Individual Access of Records under HIPAA • HIPAA Accounting of Disclosures Changes • Potential and Proposed Rules Changes • HIPAA Controls and New Technologies • Q&A 2 © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com
  • 3. Part 1 • Overview of HIPAA Regulatory Expectations – New Regulatory Directions – New Proposed Changes for the HIPAA Privacy Rule – Overdue Regulatory Action – Court Ruling Limiting Regulations – Rule Modifications and Guidance on the COVID-19 Pandemic © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 3
  • 4. Information Blocking and HIPAA • Information blocking a hot topic at HHS – New rules in place to facilitate exchange of PHI • It’s time to stop information blocking – Do what you can to facilitate patient access of records – Do what you can to facilitate transfer of records to other providers when requested by a patient • TWENTY-SEVEN settlements for not providing timely access under HIPAA since September, 2019 – Called Information Blocking penalties by HHS • Proposed changes to the Privacy Rule strengthen individual access rights and codify prior guidance and court decisions – Shorter deadlines to respond – Easier access and transmission to other providers © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 4
  • 5. Telemedicine and HIPAA • Using HIPAA-compliant fully encrypted services under a HIPAA Business Associate Agreement is fully compliant for telemedicine use – Skype for Business, Updox, VSee, Zoom for Healthcare, Doxy.me, and Google G Suite Hangouts Meet • Can follow the usual processes for Risk Analysis and secure implementation, including a HIPAA BAA • HIPAA has allowances for emergencies and life threatening situations, even without a Pendemic • Patients and providers LOVE Telemedicine! It will be with us after the emergency © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 5
  • 6. Telemedicine, HIPAA, and COVID-19 • HHS has issued an enforcement advisory on telemedicine during the COVID-19 emergency: Relaxed enforcement for using services that are non-public facing but may not meet HIPAA requirements (such as providing a BAA) – OK: Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype • BUT: Do NOT use public-facing services that are not private – Facebook Live, Twitch, TikTok, and similar • And: Once the emergency is over you will need to use HIPAA compliant services, under a Business Associate Agreement, according to a HIPAA Security Risk Analysis • See: https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency- preparedness/notification-enforcement-discretion-telehealth/index.html © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 6
  • 7. HIPAA Allowances for Communication with Family and Friends of Patients, and to Prevent a Serious and Imminent Threat • HIPAA has reasonable rules for communication and emergencies built-in • You can share information as needed with family and friends of the patient without an Authorization; get a permission if you can but don’t let it get in the way of good judgement! – Share only what’s necessary for the purpose • Sharing is permitted for Public Health purposes and in an emergency • If someone is about to get hurt, HIPAA gets out of the way – The proposed changes to the HIPAA Privacy Rule soften this to make it less dire, more reasonable to share information “in the patient’s best interest” © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 7
  • 8. Part 2 • Issues in Individual Access of Records under HIPAA – New Emphasis on Enforcement of Individual Access Rules – New Court Ruling Limiting Third-Party Access Requests – New Limitation of Business Associate Liability for Compliance © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 8
  • 9. Information Blocking Penalties in 2022 • March 28, 2022: #26 and 27: – Jacob and Associates, a psychiatric medical services provider with two office locations in California, said it would take corrective actions and pay $28,000 to settle potential violations of the HIPAA Privacy Rule, according to OCR, including provisions of the right of access standard – Dr. Donald Brockley, a solo dental practitioner in Butler, Pennsylvania, failed to provide a patient with a copy of their medical record, OCR alleges. Brockley requested a hearing before an Administrative Law Judge; the litigation was resolved before the court made a determination by a settlement agreement in which Brockley agreed to pay $30,000 and take corrective actions to comply with the HIPAA Privacy Rule's right-of-access standard © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 9
  • 10. Part 3 • HIPAA Accounting of Disclosures Changes – Current Accounting of Disclosures Requirements – Required Changes and Difficulties Implementing Them – Likely Regulation to be Proposed © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 10
  • 11. Part 4 • Potential (and Proposed) Rules Changes – Acknowledgement of Receipt of Notice of Privacy Practices – TCPA and Cell Phone Communications – Impact of Potential Changes to Affordable Care Act – Getting Back to Normal After the Pandemic Emergency © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 11
  • 12. TCPA and Communicating to Cell Phones • Telephone Consumer Protection Act of 1991 limits calls and messages to cell phones without consent • Limits Robo-calling (including reminder calls) • There are Penalties for, without consent, calling a cell phone or leaving: – A payment related message (voice or text) – A healthcare related message more than one minute (voice) or 160 characters (text) long; no more than one per day or three per week • Includes healthcare reminders, appointment reminders, etc. © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 12
  • 13. When the COVID-19 Emergency is Lifted • Allowances for using telemedicine and vaccination appointment scheduling technologies outside of a Business Associate Agreement during the emergency will be ended – Will need to switch to a HIPAA-compliant platform to continue telemedicine and vaccination scheduling • Allowances for special disclosures (such as by business associates for public health purposes) during the emergency will be discontinued © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 13
  • 14. Part 5 • HIPAA Controls and New Technologies – Difficulty in Managing Privacy – Calls for HIPAA Expansions © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 14
  • 15. New Technologies • New technologies in health care every day – Some new technologies will be very useful – Some new technologies will be a privacy and security nightmare • You can’t deny new technologies – New Technologies should be addressed head-on – If you ignore them they don’t go away – Encourage dialog on new technologies and find ways to use them productively, securely • Education addressing new technologies is essential – Prevent improper uses – Train in appropriate usage © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 15
  • 16. Security and Enforcement • Issues of portable devices & communications – Where do the responsibilities lie? • Mobile Devices in Health Care – They’re already being used – Stay Out In Front – Issues with Transmitted and Stored PHI – Office Obligations, Strategies • Clients/Patients/Consumers and Mobile Devices – Patient Rights – Patient Care – Patient Communications Policy – Documentation • Apps and Devices controlled by the individual and not provider- driven are outside of HIPAA, and are under FTC scrutiny and FTC Health Breach Notification Rules © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 16
  • 17. Guidance re HIPAA and Health Apps • Guidance addresses use of Apps by individuals, and at the request of providers https://www.fiercehealthcare.com/tech/hhs-guidance-clarifies-hipaa- liability-use-third-party-health-apps • New HHS Health Apps page: https://www.hhs.gov/hipaa/for-professionals/special- topics/health-apps/index.html • Where are the obligations for Privacy and Security? – If the patient requests communication to their App, the provider should ask about the individual’s acceptance of risk for security, and proceed as requested, no Business Associate Relationship needed – If the provider requests the patient to use an App that is working on behalf of the provider, the App provider is a Business Associate, so the provider must assure security and provide insecure communications only at the request of the individual • New Proposed HIPAA Privacy Rule changes clarify some of these obligations • Also! FTC is reviewing its rules for Breach Notification and Health Apps https://www.ftc.gov/news-events/press-releases/2020/05/ftc-seeks-comment-part- review-health-breach-notification-rule © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 17
  • 18. New Technologies and HIPAA • HIPAA can handle new technologies for PHI – Security Rule is very flexible, adaptable – For instance, have you considered Alexa and Amazon Echo? • New kinds of information, apps, devices, and various uses outside the formal HIPAA definition of “Protected Health Information” • New calls for protection of more kinds of patient information than HIPAA covers • Proposed HIPAA Privacy Rule changes would address many issues more clearly • Don’t be surprised if new laws and regulations result – Expanded FTC activity – State laws may also be in the works – Expansion of existing state breach rules © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com 18
  • 19. Your to-do list… ✓ Don’t be in denial – willful neglect costs more than compliance ✓ Keep your ears out for new rules, laws, guidance ✓ Provide individual access – don’t block information ✓ Be careful adopting new technologies ✓ Step up your Security game ✓ Make sure mobile devices are protected ✓ Document your processes for proper methods of communications with both patients and professionals ✓ Conduct drills in audit and breach response ✓ Make corrections based on results ✓ Always have a plan for moving forward, and follow it! 19 © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com
  • 20. Thank you! Learn More Here… Any Questions? For additional information, please contact: Jim Sheldon-Dean Lewis Creek Systems, LLC www.lewiscreeksystems.com 20 © Copyright 2022 Lewis Creek Systems, LLC All Rights Reserved jim@lewiscreeksystems.com www.lewiscreeksystems.com