Section 2 Flashcards
What year was COPPA enacted?
1998
Who does COPPA apply to?
Online services that specifically design for children under 13 or know that children under 13 use their services AND online services that knowingly collect children’s personal info from another online service or website targeted at children
Does COPPA apply to governments and non profits?
No except in limited circumstances where nonprofit websites are operated for the commercial benefit of their members
What additional kinds of PII apply for COPPA?
screen names, geolocation data, any media of a child’s image or voice and phone numbers AND any info collected from the child that is combined with any personal information
What rights do parents have under COPPA?
to approve of the collection and use of personal information, to revoke that consent and require the deletion of the information, and to approve of collection ONLY as necessary to use the service
What are COPPA’s general requirements?
Privacy policy, parental notification, consent and control, information security
What does a COPPA information security program have to have?
Reasonable steps to protect against unauthorized access to children’s data and procedures to delete data when it is no longer needed
What must a parental notification of a change in an organization’s practices include under COPPA?
The notice must: explain the consent process, detail the information the service intends to collect, and provide a link to the privacy policy and assure that any data collected, including contact data, will be deleted if parental consent isn’t granted.
What services must be available to parents under COPPA?
To view the personal information collected, revoke any previous consent, restrict the online service form further use of their information and have personal information deleted
Which agency(ies) enforce COPPA?
FTC. It may be enforced by states and some agencies like Department of Transportation.
What is a COPPA fine?
up to $43,280 for each violation
What happened with YouTube and COPPA?
In 2019 the FTC got a judgment against YouTube. They weren’t complying with COPPA because they didn’t think they were within its scope because the content is crowdsourced social media and not centrally managed. This helps to affirm COPPA’s application to social media companies.
Who does HIPAA apply to?
Health insurance plans, healthcare clearinghouses and healthcare providers
Plus third party businesses associates if they meet certain conditions
What are the requirements for third party individuals or organizations under HIPAA?
They must have business associate agreements that require the business associate to conform with HIPAA
What kind of records are not covered under HIPAA?
personnel records for employees, academic records covered by FERPA, and information that has been properly anonymized so it cannot be used to identify a patient
What are some HIPAA covered transactions from HHS’ guidance that aren’t on their face healthcare information?
payment and remittance advice, claims status, eligibility, coordination of benefits, claims and encounter information, enrollment and disenrollment, referrals and authorizations, and premium payments
What year was the HIPAA privacy rule established?
2000
What does the HIPAA Privacy Rule require?
- implementation of information privacy practices
- limits use and disclosure of data without patient authorization
- gives patients additional rights including the right to view and correct their medical records
Who enforces the HIPAA Privacy Rule?
HHS Office of Civil Rights (OCR)
For how long are HIPAA covered entities required to retain records related to their privacy policies (like complaints or public notices)?
Six years
Can HIPAA covered entities ask patients to waive their rights under the Privacy Rule as a condition of care or coverage?
No
What are exceptions to the HIPAA requirement that patients have access to their PHI?
- psychotherapy notes
- information gathered for legal actions
- lab results specifically restricted by the Clinical Lab Improvement Amendments
- circumstances if the entity thinks may cause the person to harm themselves or others
What are the exceptions of HIPAA for states to make use of PHI without patient consent?
- Reporting health information (birth, death records)
- Public health (reporting vital stats or enforcing regulations)
- Reporting information about health plans for oversight purpose
What is the range of fines for the OCR?
$100 up to $50K per violation
For repeated violations, up to $1.5M per year (per provision)
Is HIPAA enforcement handled through both civil and criminal?
Either or. DOJ handles criminal.
Does the HIPAA Security Rule apply to physical records?
No. Only to ePHI.
Does HIPAA preempt state laws?
Yes
What was Athens Orthopedic?
In 2016 they suffered a large data breach where a hacker stole 208K peoples information. OCR fined them $1.5M in September 2020 and consent resolution for failing to implement required protections that may have prevented the breach.
When was HITECH passed?
2009
What does HITECH do?
provides incentives for healthcare orgs to use EHR and penalties for orgs that don’t use EHR. It also includes the Breach Notification Rule.
Breach Notification Rule factors to determine if a breach has occurred
- The type of information involved and whether individual patients may be identified.
- The parties who used or access the information
- The likelihood that PHI was actually shared
- How well PHI is secured.
How long do business associates have to notify healthcare orgs of a breach under the Breach Notification Rule (HITECH)?
60 days. Then the covered entity is responsible for the rest of the notifications.
What are the notification steps for breaches under the Breach Notification Rule (HITECH) for breaches affecting fewer than 500 people?
Entities must notify victims with 60 days of discovery and report to HHS annually.
What are the notification steps for breaches under the Breach Notification Rule (HITECH) for breaches affecting more than 500 people?
They must tell HHS within 60 days, notify the victims with 60 days AND notify media outlets (usually in the form of a press release).
Do covered entities have to be able to prove they fulfilled notification requirements under the HITECH Act?
Yes. They must keep the documentation.
What are the three types of use and disclosures that are not subject to the Breach Notification Rule?
- Employee of a covered entity or BA accidentally accesses PHI but was acting in good faith
- More than one person authorized to access the same PHI accidentally share with one another
- If the entity has good reason to believe that no unauthorized parties will be able to retain the information (example - the data was fully encrypted and there was no way the information could be viewed).
How does HITECH affect BAs?
Makes them directly subject to HIPAA so OCR can pursue enforcement actions directly against the BAs
How does HITECH affect HIPAA fines?
Increases annual violation fines up to $1.5M
How does HITECH affect the HIPAA Privacy Rule?
- requires individual authorization for use of PHI in marketing
- provides the ability for individuals to revoke authorizations for disclosure
- requires healthcare orgs to maintain records of any PHI disclosures that may be viewed by patients upon request.
When was the 21st Century Cures Act passed?
2016
What does the 21st Century Cures Act do?
- Penalizes information blocking
- Sets up a framework for sharing certain mental health and substance abuse treatment information for adults with family or caregivers
- Adds privacy protections for people participating in medical research (but exempts federal govt research that could identify an individual in a FOIA request)
- Gives research participants “certificates of confidentiality” issued by the NIH
What entities are subject to “Part Two” (Confidentiality of Substance Use Disorder Patient Records Rule)?
Any substance abuse treatment program that receives federal funding
When was the Confidentiality of Substance Use Disorder Patient Records Rule passed?
1975
What are the consequences of violating the Confidentiality of Substance Use Disorder Patient Records Rule?
Fines up to $500 for first offense, and $5K for repeat. Violators may also be subject to criminal prosecution.
What kind of data is covered by the Confidentiality of Substance Use Disorder Patient Records Rule?
Any records related to alcohol or substance abuse treatment that could possibly identify an individual patient. It also restricts information that may expose a patient to criminal charges.
When was the FCRA passed?
1970