Data Compliance & Security

In case you had not heard, the European Union is replacing its current privacy laws with a new, comprehensive General Data Protection Regulation (GDPR), which takes effect May 25, 2018. The essential principles of the EU’s privacy laws are unchanged, but the new Regulation imposes many new obligations on many more entities – all backed up by fines modeled on European antitrust laws. US Life Sciences companies are likely to find that the GDPR applies to their use of personal information that originated in the EU. This post suggests some pragmatic steps companies can take to assess and begin to meet their GDPR obligations.   We’ll be presenting the next webinar in our GDPR series particularly targeted to life sciences and biotech companies and that will be coming up in March.  Watch this space for more information and registration.

Step 1 – Confirm that the GDPR Applies Continue Reading Practical GDPR Steps for US-Headquartered Life Sciences Companies

Happy 2018.  You may notice a new widget in the right sidebar of our home page.  Now you have a reminder as to just how close we are to the GDPR D-Day.    GDPR is real.   GDPR is here.

To brush up on your GDPR, or to help you get moving in the right direction, here is a link to all of the content from our 2017 GDPR webinar series.   Each edition includes a link to the recording and slides.   We will continue to produce targeted content throughout 2018, so stay tuned.

 

 Uber failed consumers in two key ways: First by misrepresenting the extent to which it monitored its employees’ access to personal information about users and drivers, and second by misrepresenting that it took reasonable steps to secure that data….This case shows that, even if you’re a fast growing company, you can’t leave consumers behind: you must honor your privacy and security promises.”  

–Acting Federal Trade Commission Chair Maureen K. Oldhausen, In the Matter of Uber Technologies, Inc., Consent Order

To read more about this important FTC Consent Order and its implications for all companies with respect to privacy policies and the promises made to users/consumers, check out this Mintz Levin Privacy Alert.

 

 

 

If you are one of the many businesses licensed by the New York Department of Financial Services (DFS), and cannot avail yourself of the (very) limited exemptions, you must be ready for the first compliance transition date for the stringent DFS cybersecurity regulations – August 28, 2017.

Just in case you’d forgotten, the DFS cybersecurity regulations became effective March 1, 2017 and you can refresh your memory here. Continue Reading Are You Ready for the New York August 28th Compliance Deadline?  

If you are a retailer with locations in New Jersey, you will need to review your procedures in anticipation of a new law effective October 1, 2017. 

New Jersey Governor Chris Christie has signed the Personal Information Privacy and Protection Act (we can now add #PIPPA to the alphabet soup of privacy acronyms…..), which limits the ability of retailers to collect PII scanned from customer driver’s licenses and identification cards and restricts the usage of any PII collected for the purposes identified in the Act.

Within recent years, retailers have commonly started a practice of scanning the barcodes on customer ID cards to verify the authenticity of an ID presented, verify identity when credit cards are used, or to prevent and control fraudulent merchandise return practices (or to identify consumers who abuse return policies).

Under PIPPA, retailers will only be permitted to scan ID cards to:

  • Verify the card’s authenticity or the person’s identity, if the customer pays for goods or services with a method other than cash; returns an item; or requests a refund or exchange.
  • Verify the customer’s age when providing age-restricted goods or services to the customer.
  • Prevent fraud or other criminal activity if the person returns an item or requests a refund or an exchange and the retailer uses a fraud prevention company or service.
  • Establish or maintain a contractual relationship.
  • Record, retain, or transmit information as required by state or federal law.
  • Transmit information to a consumer reporting agency, financial institution, or debt collector to be used as permitted by federal laws, including the Fair Credit Reporting Act, Gramm-Leach-Bliley Act, and Fair Debt Collection Practices Act.
  • Record, retain, or transmit information by a covered entity under HIPAA and related regulations.

PIPPA prohibits retailers from sharing the information with marketers or other third parties that are unknown to consumers.   It is unlikely that an online privacy notice describing sharing of scanned ID information with third parties would comply with PIPPA.  In-store notice of any such practices will likely be required.

The big “however” in this legislation is the restrictions on retention of the information when collected for the permitted purposes.  Under PIPPA businesses cannot retain information related to how the customer paid for the goods, whether the customer returned an item or requested a refund, and cannot store ages.   Retailers will only be permitted to collect the customer’s name, address, and date of birth; the issuing state; and the ID card number.    Any of this information collected from scanned ID cards Is required to be “securely stored” and PIPPA makes it clear that any security breach of this information is subject to New Jersey’s data breach notification law and must be reported to any affected individual and the New Jersey State Police.

And there are penalties.   PIPPA provides civil penalties of $2,500 for a first offense, and $5,000 for any subsequent offices.   Further the law allows for “any person aggrieved by a violation” to bring an action in NJ Superior Court to recover damages.

 

Recently the United States Computer Emergency Readiness Team (US-CERT), an organization within the Department of Homeland Security’s (DHS) National Protection and Programs Directorate (NPPD) and a branch of the Office of Cybersecurity and Communications’ (CS&C) National Cybersecurity and Communications Integration Center (NCCIC), encouraged users and administrators to review a recent article from the Federal Bureau of Investigation (FBI) regarding Building a Digital Defense with an Email Fortress.

Are we have discussed in many posts before, phishing — the fraudulent practice of sending emails purporting to be from a reputable entity to induce an individual to reveal privileged information such as a password — remains a major security threat.  Within the article, the FBI provides several helpful actions for businesses can take to reduce their risk of being phished, including reporting and deleting suspicious e-mails, and making sure that countermeasures such as firewalls, virus software, and spam filters are robust and up-to-date.

We encourage each of our readers to review the FBI’s guidance and consider whether their organization could benefit from any of the methods of protection provided.

Companies with any questions regarding any of these issues should not hesitate to contact the team at Mintz Levin.

At last week’s Health Care Compliance Association’s annual “Compliance Institute,”  Iliana Peters, HHS Office for Civil Rights’ Senior Advisor for HIPAA Compliance and Enforcement, provided a thorough update of HIPAA enforcement trends as well as a road map to OCR’s current and future endeavors.

Continuing Enforcement Issues

Ms. Peters identified key ten enforcement issues that OCR continues to encounter through its enforcement of HIPAA.  Do any of them look familiar to you? These issues include:

  1. Impermissible Disclosures. HIPAA’s Privacy Rule prohibits covered entities and business associates from disclosing PHI except as permitted or required under HIPAA. Impermissible disclosures identified by Ms. Peters all center on the need for authorization, and include:
    • Covered entities permitting news media to film individuals in their facilities prior to obtaining a patient’s authorization.
    • Covered entities publishing PHI on their website or on social media without an individual’s authorization.
    • Covered entities confirming that an individual is a patient and providing other PHI to reporters without an individual’s authorization.
    • Covered entities faxing PHI to an individual’s employer without the individual’s authorization.
  2. Lack of Business Associate Agreements. OCR continues to see covered entities failing to enter into business associate agreements.
  3. Incomplete or Inaccurate Risk Analysis. Under HIPAA’s Security Rule, covered entities are required to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic PHI (ePHI). According to Ms. Peters, organizations frequently underestimate the proliferation of ePHI throughout their environment, including into systems related to billing, faxing, backups, and medical devices, among others.
  4. Failure to manage identified risks. HIPAA requires regulated entities to put in place security measures to reduce risks and vulnerabilities. According to the presentation, several OCR breach investigations found that the causes of reported breaches were risks that had previously been identified in a risk analysis but were never mitigated. In some instances, encryption was included as part of the remediation plan, but was never implemented.
  5. Lack of transmission security. While not required in all cases, HIPAA does require that ePHI be encrypted whenever it is deemed appropriate. The presentation identified a number of applications in which encryption should be considered when transmitting ePHI, including email, texting, application sessions, file transmissions (e.g., FTP), remote backups, and remote access and support services (e.g., VPNs).
  6. Lack of Appropriate Auditing. HIPAA requires the implementation of mechanisms (whether hardware, software or procedural) that record and examine activity in systems containing ePHI. HIPAA-regulated entities are required to review audit records to determine if there should be additional investigation. The presentation highlighted certain activities that could warrant such additional investigation, including: access to PHI during non-business hours or during time off, access to an abnormally high number of records containing PHI, access to PHI of persons for which media interest exists, and access to PHI of employees.
  7. Patching of Software. The use of unpatched or unsupported software on systems which contain ePHI could introduce additional risk into an environment. Ms. Peters also pointed to other systems that should be monitored, including router and firewall firmware, anti-virus and anti-malware software, and multimedia and runtime environments (e.g., Adobe Flash, Java, etc.).
  8. Insider Threats. The presentation identifies insider threats as a continuing enforcement issue. Under HIPAA, organizations must implement policies and procedures to ensure that all members of its workforce have appropriate access to ePHI and to prevent those workforce members who do not have access from obtaining such access. Termination procedures should be put in place to ensure that access to PHI is revoked when a workforce member leaves.
  9. Disposal of PHI. HIPAA requires organizations to implement policies and procedures that ensure proper disposal of PHI. These procedures must guarantee that the media has been cleared, purged or destroyed consistent with NIST Special Publication 800-88: Guidelines for Media Sanitization.
  10. Insufficient Backup and Contingency Planning. Organizations are required to ensure that adequate contingency planning (including data backup and disaster recovery plans) is in place and would be effective when implemented in the event of an actual disaster or emergency situation. Organizations are required to periodically test their plans and revise as necessary.

Upcoming Guidance and FAQs

OCR also identified upcoming guidance and FAQs that it will use to address the following areas:

  • Privacy and security issues related to the Precision Medicine Initiative’s All of Us research program
  • Text messaging
  • Social media
  • Use of Certified EHR Technology (CEHRT) & compliance with HIPAA Security Rule (to be release with the Office of the National Coordinator for Health Information Technology (ONC))
  • The Resolution Agreement and Civil Monetary Penalty process
  • Updates of existing FAQs to account for the Omnibus Rule and other recent developments
  • The “minimum necessary” requirement

Long-term Regulatory Agenda

The presentation also identifies two long-term regulatory goals to implement certain provisions of the HITECH Act. One regulation will relate to providing individuals harmed by HIPAA violations with a percentage of any civil monetary penalties or settlements collected by OCR, while the second will implement a HITECH Act provision related to the accounting of disclosures of PHI.

Audit Program Status

The presentation discussed the current status of OCR’s audit program. As we have previously discussed, OCR is in the process of conducting desk audits of covered entities and business associates. These audits consist of a review of required HIPAA documentation that is submitted to OCR. According to Ms. Peters, OCR has conducted desk audits of 166 covered entities and 43 business associates. Ms. Peters also used the presentation to confirm that on-site audits of both covered entities and business associates will be conducted in 2017 after the desk audits are completed. We will continue to follow and report on developments in the audit program.

Commentary

The list of continuing enforcement issues provides covered entities and business associates with a helpful reminder of the compliance areas that are most likely to get them in compliance trouble. Some of the enforcement issues may require HIPAA-regulated entities to revisit decisions that they previously made as part of a risk analysis. Transmission security (#5, above) is an example of such an area that may warrant reexamination. In the past, encrypting data was often too expensive or too impracticable for many organizations. However the costs of encryption have decreased while it has become easier to implement. A covered entity or business associate that suffers a breach due to transmitting unencrypted PHI over the internet will likely garner little sympathy from OCR going forward. The presentation is also notable for the long list of guidance and FAQs that OCR will be publishing, as well as their plan to issue regulations to address changes ushered in by the HITECH Act that were not captured by the 2013 Omnibus Rule. These regulations, particularly the regulations related to accounting for disclosures of PHI, could have a far-reaching impact on how covered entities and business associates comply with HIPAA in the future.

 

Last week, Snap Inc. (“Snap” or the “Company”) – the parent company of the wildly popular app Snapchat (“Snapchat” or the “App”) – became a publicly traded company on the New York Stock Exchange in the biggest tech IPO since Alibaba in 2014.  Priced at $17 per share, the Snap stock opened at $24 per share on Thursday morning and closed at $24.48 per share, bringing the Company’s market capitalization to approximately $28 billion. In today’s post, we’re taking a closer look at Snap’s S-1 filing (“Snap S-1”) with the U.S. Securities and Exchange Commission (SEC) with a particular focus on the Company’s disclosures of risk factors associated with cybersecurity and privacy risks.  Continue Reading A Deep Dive into Privacy/Security Disclosures in Snap’s S-1