Biden Administration to End COVID-19 PHE on May 11

Originally published in the February 2, 2023, issue of MGMA’s Washington Connection
Reprinted with permission from MGMA

The Biden Administration announced that it plans to end the COVID-19 public health emergency (PHE) on May 11, 2023. This decision comes after multiple renewals over the past three years. MGMA appreciates that the Administration heeded our call to provide at least 90-days’ notice prior to concluding the PHE. The end of the PHE will have ramifications for a variety of flexibilities afforded by the pandemic over the last several years, such as HIPAA penalty waivers, controlled substance prescription waivers, and COVID-19 testing and treatment coverage.

For more information on the flexibilities that will conclude along with the PHE, download MGMA’s member-exclusive resource.

5 Best Practices for Keeping Your Patient’s Medical Data Safe

2022 Alliance sponsor feature article courtesy of TowneBank

Medical identity theft has more than tripled over the past five years, as hackers and cyber-criminals target the healthcare industry at alarming rates. So why are medical records so valuable to data thieves? Personal medical data is said to be more than ten times as valuable as credit card information. Just one patient record contains an enormous amount of identity information that hackers can exploit, including:

• Full name
• Birth date
• Social Security number
• Medicare number
• Email
• Phone numbers
• Home address
• Prescription information
• Driver’s license
• Payment information such as credit card or bank account numbers

This data is incredibly valuable on the black market, just one Medicare number is said to sell for nearly $500. Keeping this patient information safe from cyber-thieves must be a top priority for hospitals, healthcare organizations, and medical offices. The threat of a data breach not only puts an organization or medical practice at risk for a hefty fine or HIPAA violation, but it also threatens the core of the business because it damages patient trust.

The following are five steps to keeping your patient’s medical data safe:

1) Education
Educating your staff may be the best line of defense against data theft. Ensure your employees are informed on privacy policies, security measures, how data breaches occur and how to prevent them. Build staff awareness of medical identity theft and how to keep patient data secure.

2) Mobile devices
Patient data may often be stored on mobile devices. Protecting devices such as laptops, smartphones, and tablets with encryption and passwords is another way to avoid a potential data breach. Also, it is important to ensure employees never leave their mobile devices unattended.

3) Email
Many attempts for data breach occur through unsolicited emails called “phishing.” Be sure to instruct staff not to open any emails that are unfamiliar and never open any attachments or links from an unknown sender.

4) Antivirus
Be sure to keep all software and antivirus programs regularly up to date.

5) Secure your network server and wireless networks
To prevent attacks, practices should make sure their network passwords are secure and changed frequently. Ensure routers and other components are kept up to date. Set up firewalls and antivirus for all devices that connect to the internet. Lock down your network server so that it is difficult to physically remove it from your office and lock up any backup or storage devices.

Common mistakes:

• Employees sharing workstations or user IDs
• Leaving screens or workstations unsecured
• Sending patient medical information via unsecured email
• Using unsecured laptops, tablets, and smartphones
• Sending patient medical information through text messaging
• Speaking about private patient medical information to friends, family, patients, or other medical offices.
• Failure to obtain the proper release/consent form to release patient medical data.

While there is not one sure way to prevent all data breaches, these best practices will go a long way in keeping your patient data safe and secure from potential theft.

Learn more and access more insights and perspectives through the TowneBank Business Resource Center.

The information provided is not intended to be legal, tax, or financial advice or recommendations for any specific individual, business, or circumstance. TowneBank cannot guarantee that it is accurate, up to date, or appropriate for your situation. Financial calculators are provided for illustrative purposes only. You are encouraged to consult with a qualified attorney or financial advisor to understand how the law applies to your particular circumstances or for financial information specific to your personal or business situation.

The OCR’s Notorious Wall of Shame

Originally published by HealthMark Group on January 13, 2022
2022 Alliance sponsor feature article courtesy of HealthMark Group

Avoiding HIPAA Breaches and the “Wall of Shame”

Ever-evolving developments in healthcare technology, aimed at increasing efficiency and access, are growing at an exponential rate. That may offer more effective processes and support better care coordination, but it also leaves many practitioners finding it exceedingly difficult to remain compliant amid all of the security measures guided by the Health Insurance and Patient Accountability Act (“HIPAA”). Whether dealing with staffing shortages, clinic expansion, or a lack of training, avoiding breaches of personal health information (“PHI”) is both a top priority and an ongoing challenge.

When breaches do occur, HIPAA requires they be reported to the U.S. Department of Health & Services Office for Civil Rights (“OCR”). Violations affecting 500 individuals or more must be reported within 30 days of discovery to impacted individuals and within 60 days to the OCR and local media. OCR also publishes information identifying these breaches on what has become known as the OCR “Wall of Shame”. Established under the HIPAA Breach Notification Rule and HITECH Act, the Wall of Shame lists the names and other details of organizations under investigation due to a violation that has occurred within the last 24 months. To state the obvious, you do not want to be placed on this list.

Recent Statistics

• In 2021, 607 violations affecting nearly 45 million individuals were submitted to the OCR and are now visible on the Wall of Shame (a 20% increase in breaches compared to 2019, only two years prior) ¹
• Breaches have increased 84% in the last five years, with 329 reported in 2016²
• The average cost per record breached hit $499 in 2020 on an upward trend, totaling $13.2 billion for the year³
• Unauthorized access/disclosure accounts for 34% of violations every year, up 162% over the past three years⁴
• Hospitals typically account for 30% of all large data breaches⁴

Potential Financial Consequences

Most often, the OCR resolves cases through voluntary compliance or by accepting a covered entity’s plan to address the breach and adjust policies and procedures to avoid future violations. For severe cases, the Enforcement Final Rule of 2006 allows the OCR to issue financial penalties to covered entities that fail to comply with HIPAA Rules. There are currently four main tiers of such violations⁵:

• Tier 1, $100 – $50,000 per breach: A violation that the covered entity was unaware of and could not have reasonably avoided.
• Tier 2, $1,000 – $50,000 per breach: A violation that the covered entity should have been aware of but could not have avoided.
• Tier 3, $10,000 – $50,000 per breach: This violation is considered to be the result of willful neglect in instances where corrective measures were taken within a reasonable timeframe.
• Tier 4, $50,000 per breach: This violation is considered to be the result of willful neglect in instances where no corrective measures were taken to resolve the breach.

While less common, criminal penalties do exist in addition to fines for various violations, including malicious intent (i.e., selling data for harm or commercial gain).

How HealthMark Can Help

With management of PHI at the core of HealthMark’s business, it remains the highest priority to keep data secure and compliant. Our team responsible for the handling of medical records is required to undergo Certified Release of Information Specialist (“CRIS”) training and certification to demonstrate understanding of patient privacy rights and HIPAA requirements. Guidelines around HIPAA, the Privacy Rule, Information Blocking, etc. are constantly evolving, making regulatory education one more thing for practices to manage. Our goal as a partner is not only to offer services that ease administrative loads, but to also do the work for clients by combing through often convoluted details and staying abreast of the most important changes that are occurring. By doing so, we can share with clients what they need to know and when, which allows our clients to focus more of their limited resources on their primary goal of patient care.

1. https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf
2. https://www.hipaajournal.com/largest-healthcare-data-breaches-of-2016-8631/
3. https://www.beckershospitalreview.com/cybersecurity/healthcare-data-breaches-up-55-1-in-2020-report-finds.html
4. https://techjury.net/blog/healthcare-data-breaches-statistics/#gref
5. https://www.hipaajournal.com/what-are-the-penalties-for-hipaa-violations-7096/

March 23rd Lunch & Learn Webinar: COVID Vaccine Planning & Resources

March Lunch & Learn Webinar
Arm Yourself: COVID Vaccine Planning & Resources

Tuesday, March 23rd | 12:00 PM – 1:00 PM EDT

This program will provide an overview of key considerations in planning a COVID-19 vaccine administration program in a medical practice and will touch on some available resources that can be accessed to prepare. Topics covered will include:

• Planning and organizing the effort
• Selecting and training staff to administer vaccine
• Administration of the vaccine and documenting immunizations
• Planning for contingencies
• Addressing HIPAA compliance issues

Webinar Speaker

Bill Shenton
Partner, Poyner Spruill
Bill Shenton is a partner in the Raleigh office of Poyner Spruill. During the course of his law practice, he has represented the NC DHHS for over forty years; and in private practice, has represented and advised health care providers and organizations in civil and administrative litigation, and on various regulatory compliance issues.

Registration

This webinar is free but you must be registered to attend. Space is limited so register early! After you register, you will receive an email confirmation and an email reminder with webinar login instructions.

Register Online Today

Continuing education credit may be granted through your professional organization (MGMA, PAHCOM, AHIMA, etc.). Please self-submit for these organizations.

Questions

For questions or more information please contact the NC Medical Society offices at ncmsfoundation@ncmedsoc.org.

The HIPAA Privacy Rule’s Right of Access

2020 Alliance sponsor feature article courtesy of Total Medical Compliance

One of the key goals of The Health Insurance Portability & Accountability Act of 1996 (HIPAA) is to ensure patients have the ability to access their protected health information (PHI) in a timely manner and in the format most convenient for them. Some providers have implemented electronic health record systems that offer patients the ability to view and download their health records at any time. However, patients do not always take advantage of that option. Some rather have a hardcopy of their records, or certain records might not be stored electronically. In these cases, a patient will submit a request for a copy of their health records.

HIPAA requires a provider to respond to a request from a patient for their health records (with some exceptions, like psychotherapy notes) as quickly as possible. The provider has up to 30 days to respond to the request, but The U.S. Department of Health & Human Services (HHS) strongly encourages providers to respond sooner, especially if the information is already in electronic format. An extension of 30 additional days is permitted, but the patient must be provided notice of the extension in writing along with the reason for the extension within the first 30 days. Some state laws require requests to be addressed in a shorter period of time.

A provider cannot refuse a patient’s request to send health records to them via unencrypted email if the patient has been informed of and has accepted the risk associated with the unencrypted transmission of their health record. The provider’s access request form should include an area where the patient can acknowledge that they accept the risk of having their records sent via unencrypted email.

Last year, HHS launched an initiative to “vigorously enforce the rights of patients to get access to their medical records promptly, without being overcharged, and in the readily producible format of their choice.” Since then, the HHS Office for Civil Rights (OCR) has settled 2 cases regarding a patient’s right to access health records. The most recent one was in December 2019. A penalty of $85,000 and a 1-year corrective action plan were imposed by the OCR. The first enforcement action was in September 2019 under the same terms. The decision emphasized, “This right to patient records extends to parents who seek medical information about their minor children.” It is hard to say whether that will be the OCR’s standard enforcement arrangement, but history shows that generally, penalties have been decided on a case by case basis.

A reasonable, cost-based fee can be assessed, but HHS encourages providers to give records (especially if in electronic format) to patients at no cost when possible. It is important to note, though, that a patient does not lose their right to access their health record even if they have an outstanding balance with a provider. The fundamental point is clear: a patient’s access to their health record may not be obstructed or delayed by a provider, so it is important to be diligent and address a patient’s request as soon as possible.

Tips for Responding to Online Reviews

2020 Alliance sponsor feature article courtesy of MagMutual

Top Five Recommendations:

Acknowledge feedback quickly – Consumers turn to social media for information and expect healthcare organizations to monitor online feedback, especially on their own social media pages and high-traffic sites. It’s important for organizations to perceive online reviews as valuable patient feedback. Acknowledging those activities validate patient feelings and show an organization’s commitment to providing quality care. Consider having individuals closely monitoring accounts and providing feedback within 24 hours.

Keep responses anonymous – It is extremely important to maintain HIPAA compliance when responding to online reviews. By providing generic responses, without PHI or individual patient care details, an organization can safeguard itself against fines and other penalties.

Adhere to standard protocols – Create and follow standard protocols for responding to online reviews. Determine the appropriate individual(s) to monitor online feedback. Establish time frames for online feedback reviews and responses. Use pre-approved, HIPAA-compliant responses for positive and negative feedback. If possible, remove feedback that contains offensive language or hate speech and use a templated statement about removing that type of language.

Use templated responses – Developing a few responses for positive and negative reviews can ensure that they are generic, HIPAA-compliant, timely and remove any bias or anger that might present itself in individual responses. These templates can be reviewed by your insurance risk management team and providers for approval and quickly used when a new review is submitted.

Address direct issues offline – If an organization receives an online review with allegations of negligence or non-factual information, use a generic response online and don’t address any specifics. If appropriate, ask the reviewer to contact the organization to address any concerns. Communication over the phone or in person will increase the likelihood of understanding and compromise.

Top Five Cautions:

Don’t respond in anger – Unfortunately, there are times when consumers will post incorrect, rude or defamatory reviews. Responding in anger could lead to HIPAA privacy violations or online back and forth fighting for the world to see. It’s better to use a templated response and try to address the issue offline.

Don’t private message – Online messaging and email is not private, and HIPAA violations may occur if PHI is included in any online activities on behalf of an organization.

Don’t give medical advice – Medical advice, appointment scheduling, medication prescriptions/refills, lab results, billing issues, etc. should never be provided or discussed online. Those actions should only be conducted with established patients in person, over the phone or through a secure healthcare portal after patients have consented to participate and understand emergency issues shouldn’t wait for online portal responses.

Don’t delete reviews – Consumers understand that even the best organizations and providers receive negative online reviews. Unless the review contains profane language or hate speech, organizations should leave the review and ensure they have responded, showing other consumers that they review feedback and are committed to communication and improving their quality/service.

Don’t alter content – Loss of confidence in an organization will occur if responses are altered. In today’s world, online consumers routinely take screen shots of online reviews and reply messages. If a message is altered, the evidence might still remain available and could be used against an organization. Also, it’s important to remember that patients can disclose their own PHI, but the organization cannot repeat or verify/deny without authorization.

Sample Online Compliment/Complaint Responses:

Compliment – Our practice aims to deliver the highest quality patient care. We love to hear about positive experiences. Thank you for your comments.

Compliment – Thank you so much. We really appreciate your kind words and will be sure to pass your feedback on to the staff.

Compliment – Thanks for sharing this feedback with us!

Complaint – Thank you for sharing your feedback with us. We apologize for your recent experience. Please call us at [phone number] so we can improve next time.

Complaint – We are sorry to hear about your experience. We are committed to providing the best patient care. Please contact us at [phone number] so that we may speak with you and address any concerns.

Complaint with profanity – Your message was removed because it did not meet our site standards. If you have any questions or concerns, please contact our office at [phone number].

A Step-by-Step Guide for Responding to Medical Record Subpoenas

By Raj Shah, Esq., Senior Regulatory Attorney, MagMutual

2020 Alliance sponsor feature article courtesy of MagMutual

Healthcare providers are aware that HIPAA and state privacy laws place restrictions on the disclosure of protected health information (PHI) to third parties. If a request for records comes via subpoena, discovery request or any other court order, the provider must not ignore it because a response is usually required. However, while you shouldn’t ignore the subpoena or discovery request, the consequences of responding incorrectly to a request can be even more severe than those of ignoring it altogether. Once a subpoena is received, DO NOT ignore it, but also DO NOT immediately disclose the records, as you could be in violation of HIPAA or state privacy laws and face severe penalties. This article offers guidance about what to do and what not to do after being served with a subpoena or request for documents including PHI.

Step 1: Check if the Request is Signed by a Judge

Court Orders, Court-Issued Subpoenas and Grand Jury Subpoenas. If you receive a court order or a subpoena that is signed by a judge, magistrate, administrative tribunal or a grand jury subpoena, you must disclose the requested information. Still, remember to disclose only the information expressly requested, and nothing more. For example, if the subpoena asks for records relating to a specific date of service, only send records from that day and not the patient’s whole record. (If the document you received meets these criteria, there is no need to go on to the other steps, but additional information is available at the end of this document.)

Practical Advice: Look specifically for a checkbox or judge’s signature on the subpoena form to confirm the subpoena is signed by a judge and not the court clerk or attorney. The judge’s name should also be listed in print next to the signature.

Step 2: Responding to Lawyer or Clerk Signed Requests

Attorney-Issued Subpoenas or Discovery Requests. A subpoena or discovery request signed by someone other than a judge, magistrate or administrative tribunal – most likely a court clerk or an attorney – is NOT a court order. A subpoena signed by an attorney or a court clerk requires additional assurances under HIPAA. If you receive a subpoena or discovery request that is signed by an attorney or court clerk, you can not disclose information unless one of the following conditions are satisfied:

1. Provider must receive a written statement and accompanying documentation from the attorney issuing the subpoena demonstrating that:
   1. A good faith attempt was made to provide written notice of the subpoena to the patient or his or her attorney (this can be satisfied by a cover letter accompanying the request that that patient’s attorney was notified via a carbon copy);
   2. The written notice included sufficient information to allow the patient to raise an objection to the subpoena;
   3. The time for objecting to the subpoena has passed; and
   4. The patient did not object to the subpoena or that any objections by the patient were adequately resolved by the court.
2. Provider makes reasonable efforts to provide notice of the subpoena to the patient and the patient does not make any objections to the release of their PHI.
   1. Examples of reasonable efforts to notify the patient include calling the patient or sending the patient a letter via mail or email explaining that you’ve received a subpoena requesting disclosure of their protected health information, and you are required to respond unless the patient has the subpoena set aside before the time for responding has expired and notifies you that the subpoena has been set aside.
3. Provider may obtain a valid authorization form signed by the patient for the release of their records. This is the provider’s HIPAA authorization that patients in the office routinely sign to obtain their PHI. To be valid, the authorization form must contain the elements and statements required by the HIPAA Privacy Rule. The form also must be signed by the appropriate person, which may be the patient or may be the patient’s personal representative (if, for example, the patient is a child or an incapacitated adult).
   Practical Advice: If a subpoena is accompanied by an authorization or other document labeled “release” or “waiver” or something similar DO NOT USE IT. Some of the elements of an authorization that make it HIPAA-compliant are not intuitive and may be left out of a form prepared by a person (even an attorney) who is unaccustomed to working with HIPAA. If you receive a subpoena with an attached authorization for the patient to sign, do not use it and use your practice’s HIPAA authorization form instead.
4. Provider must receive a written statement and supporting documentation demonstrating:
   1. that the parties have agreed on a qualified protective order or
   2. that the party seeking the information has filed for a qualified protective order. A qualified protective order limits the use of the requested PHI to the lawsuit.
5. Provider makes reasonable efforts to obtain a qualified protective order.

If for some reason the provider cannot satisfy one of these five conditions, they may not disclose the requested PHI, but neither may they ignore the subpoena without subjecting themselves to possible contempt sanctions. Staff members should notify their supervisors if one of these conditions are not met. The supervisors will be able to contact the organization’s attorney or a risk consultant at MagMutual who can provide guidance.

Step 3: See What Information is Being Requested

After determining the attorney-signed subpoena is valid, look at what information is being requested and be sure to provide only what was requested. In most states, for example, a subpoena must specifically ask for specially protected records such as those related to mental health and substance abuse. A subpoena asking for all of a patient’s medical records would not be sufficient to obtain those documents. See the examples below.

1. General Request for Entire Record. If the subpoena is for a patient’s entire medical record, release the record except for specially protected records. Specially protected records include mental health records; drug/alcohol treatment records; psychotherapy notes; testing for or treatment of HIV, AIDS and STDs; and mental health, behavioral health or treatment records of substance abuse programs. If you are unsure if a part of the record is specially protected, ask a supervisor.Practical Advice: Remember when communicating with the party seeking the record, even mentioning the existence of this highly sensitive PHI could be a HIPAA violation. For example, do not say, “We can send over the record except for the HIV treatment information.”
2. Requests for Specially Protected Records. If the request specifically asks for specially protected records, they can only be released under one of the following conditions:
   1. A court order signed by a judge specifically ordering the records related to these specially protected areas; or
   2. A valid authorization signed by the patient specifically authorizing the practice to release that portion of the record.

Step 4: Watch and Diary the Calendar

Once you know which records to send, pay attention to the calendar. Note the date by which the records are required, which sometimes can be too soon for the provider to comply. A short deadline also doesn’t allow enough time if the patient must be contacted for authorization or for the patient to object to the subpoena. It is not unusual for a subpoena to request records be delivered within a week. If the time to respond seems too short, contact your supervisor. If no time to respond to the subpoena is listed, you should respond after 21 days (ideally between 21 and 25 days). Remember, do not immediately respond even if it is a valid subpoena. This gives the patient time to sign an authorization or file an objection.

General Checklist for Responding to a Subpoena Requesting Protected Health Information

These are steps to be taken to comply with a subpoena while at the same time protecting patient privacy and confidentiality. A provider should do the following:

1. Confirm that the subpoena is valid (if it’s from an out-of-state court, it’s probably invalid)
2. Identify who signed the subpoena (e.g., judge, administrative agency, attorney, court clerk)
3. If the subpoena is signed by an attorney, contact the party issuing the subpoena to obtain satisfactory written assurances or a qualified protective order.
4. When the subpoena is requesting records relating to a limited number of patients, notify the patients whose records are being sought as already outlined and/or determine whether the patients will provide a valid HIPAA authorization that complies with HIPAA. (Remember you can use either a MagMutual authorization form or your practice’s existing authorization form.)
5. If there are any questions about whether or which documents can be produced, ask your supervisor.
6. Consider whether other laws in addition to HIPAA limit disclosures (e.g., state law limits on disclosures for mental health records and drug/alcohol treatment records).

Considerations for Deceased Patients

If a subpoena is requesting the medical records of a deceased patient, the same rules listed above apply, except that any authorization must be given by a “personal representative” of the deceased patient. The executor of the patient’s estate is a “personal representative” and may sign the authorization as well as be substituted for the deceased patient for the purpose of notice or qualified protective orders. The patient may also sign a HIPAA release prior to death that designates an individual to have access to their PHI. Even if not an executor or specifically designated by a HIPAA authorization form, family members or individuals involved in the patient’s care may also be “personal representatives” if the request is relevant to their involvement in the patient’s care, unless releasing the records is against the preference of the deceased patient.

The 411 on HITECH and HIPAA IT Compliance

By Judi Grassi

2020 Alliance sponsor feature article courtesy of Carolinas IT: A Logically Company

Most group practices and clinics have adopted the Electronic Health Record (EHR). If you’re one of these organizations, you know how imperative it is to keep your Electronic Protected Health Information (EPHI) safe. Both HIPAA and the HITECH Act lay out very specific requirements about data protection and regardless of your size, you are required to keep your Protected Health Information (PHI) data secure. This is especially imperative if your organization electronically transmits health information for financial or administrative reasons, such as claims processing, benefit eligibility, referral authorization requests, and other transactions defined under the HIPAA Transactions Rule.

Three Areas of HIPAA IT Compliance

HIPAA IT compliance is the responsibility of every administrative and clinical staff member in your organization. To make compliance requirements easier to digest, HHS established three areas of HIPAA IT compliance.

1. 1. Administrative — These measures ensure the integrity of patient data and accessibility only to authorized parties. It requires HCOs to:
      • Implement a security management process that identifies potential risks to EPHI and appropriate security measures to reduce risks and vulnerabilities.
      • Designate a security official who is responsible for ensuring HIPAA and HITECH compliance.
      • Identify who has authorized access to EPHI.
      • Provide appropriate security training to employees and follow through with appropriate sanctions against any employee who violates security policies.
      • Perform a periodic assessment to assess the effectiveness of your security policies.
   2. Physical — These measures ensure the security of facilities and devices that contain EPHI. It provides HCOs to:
      • Limit physical access to their facilities to authorized personnel only and protect against physical intrusion.
      • Ensure secure access to workstations and electronic media. This includes procedures for the transfer, removal, disposal, and re-use of electronic media to ensure appropriate protection of EPHI.
   3. Technical — These measures ensure that your IT systems and networks are secure from data breaches and unauthorized access. It requires HCOs to:
      • Protect their IT systems against digital intrusion and ensure that EPHI is transmitted over a secure network.
      • Only allow authorized individuals to access EPHI and ensure IT systems provide an audit trail to track EPHI access.
      • Ensure EPHI is not improperly or erroneously altered or destroyed.

HITECH Compliance

The HITECH Act of 2009 shored up these privacy and security provisions:

• HCOs, business associates, and service providers are all responsible for the security of EPHI.
• HCOs must promptly notify affected individuals whose PHI was compromised.
• HCOs must report any security breach that affects more than 500 individuals to the HHS Secretary.
• HCO business associates must notify the HCO of any breach at or by the business associate.
• Breaches affecting fewer than 500 individuals must be reported to the HHS Secretary on an annual basis.

How to Comply with HIPAA and HITECH Technical Measures
Whether you are a hospital, clinic, medical practice, HCO business associate, or HCO service provider, you will need to address the following in order to comply with HIPAA and HITECH technical measures.

• Develop policies and procedures for data backup and recovery.
• Back up your data on a regular, frequent basis and ensure you can retrieve exact copies of EPHI and restore any lost data. Follow the 3-2-1 backup rule: 3 copies of your data across 2 media with 1 copy stored offsite.
• Establish acceptable but aggressive Recover Time Objectives (RTOs) and Recovery Point Objectives (RPOs) and develop a disaster recovery plan that meets these objectives.
• Periodically test your disaster recovery plan to be sure it works before a real disaster happens.
• Perform an annual risk assessment to determine whether your systems and data are a security risk and how vulnerable you are to attack.
• Develop a data breach response plan to identify who is responsible for what when a breach occurs, how to communicate with individuals whose PHI was compromised, how to handle the media, minimize further data loss, and remediate the breach.
• Encrypt EPHI data in transit and at rest.
• Ensure HCO business associates and service providers meet HIPAA and HITECH security requirements.

Noncompliance Fines
If you are found in noncompliance with HIPAA and HITECH regulations, it can cost you. Fines are based on the violation category or level of perceived negligence and can range from $100 to $50,000 per violation, with a maximum penalty of $1.5 million per year for each violation (see Figure 1).

Figure 1

If you are breached and fined, your organization is listed on the HHS Office for Civil Rights (OCR) Breach Portal and “Wall of Shame” if the breach involves 500 or more individuals. If your organization has a breach of this magnitude, the name of your HCO will be permanently listed.

Final Thoughts

HCOs have two choices when it comes to HIPAA IT compliance requirements: DIY (Do It Yourself) or hire an IT Managed Service Provider (MSP). Whether you are a large or small HCO, you may find that you have limited IT resources and/or skills in-house to ensure your EPHI is private and secure. Therefore, many HCOs look to HIPAA-compliant MSPs to back up their systems, ensure the privacy of EPHI, and provide the best protection from security breaches.

Figure 1: Categories of Violations and Respective Penalty Amounts Available. Source: https://www.federalregister.gov/documents/2013/01/25/2013-01073/modifications-to-the-hipaa-privacy-security-enforcement-and-breach-notification-rules-under-the#h-95

HIPAA Privacy and Coronavirus

2020 Alliance sponsor feature article courtesy of Total Medical Compliance

While preparing and treating patients that have or might have novel coronavirus (2019 nCoV), it is important to remember your patient’s privacy rights. HIPAA permits the sharing of patient’s protected health information (PHI) for public health activities such as this without a patient authorization.

With whom and when can you share PHI for public health activities? Generally, PHI can be shared with:

• entities that are permitted by law to collect and receive health information for the purpose of preventing or controlling disease such as the CDC or a state or local health department,
• organizations such as the American Red Cross,
• others at risk of contracting or spreading a disease or condition if state law authorizes the covered entity to notify others as necessary to prevent or control the spread of the disease, and
• others involved in the patient’s care such as family and friends. Providers should use their professional judgement here and obtain verbal consent from the patient, if possible.

PHI should not be shared with the media or others not involved in a patient’s care without the patient’s authorization.

The HIPAA minimum necessary standard still applies to the use and disclosure of PHI. The U.S. Department of Health and Human Services says that entities may rely on representations from the CDC or other public health department that the PHI requested by them about all patients exposed to or suspected or confirmed to have novel coronavirus (2019-nCoV) is the minimum necessary. In addition, a covered entity should continue to limit access to PHI to only those workforce members who need it to carry out their duties.

Will the GDPR Affect your Practice?

By Debra Gordick, Total Medical Compliance

2019 Alliance feature article courtesy of Total Medical Compliance (TMC)

What is the GDPR? General Data Protection Regulations (GDPR) is a set of laws passed by the European Union in May 2018, to provide rules for protecting electronic data on individuals in the European Union (EU). These regulations include similar security restrictions for Europe as HIPAA does for the USA. One of the biggest differences is that the information being protected is all private data not just health information. The GDPR also targets the information from companies that track consumer’s internet history for the purpose of marketing products and services.

Why should laws passed in Europe matter to US companies? The GDPR is enforceable to any company that falls within the rules whether they are European or not. Additionally, other countries in Europe, Asia and Africa are starting to adopt the GDPR. This raises two questions:

• What would make you subject to the GDPR?
• Will the US adopt the same or similar laws as the GDPR?

1. What would make you subject to the GDPR?

Contrary to what the salespeople are telling you, it is unlikely that you will be covered under the GDPR. The official website of the European Union (EU) states that the GDPR does not apply to your business if: “Your company is a service provider based outside the EU. It provides services to customers outside the EU. Its clients can use its services when they travel to other countries, including within the EU. Provided your company doesn’t specifically target its services at individuals in the EU, it is not subject to the rules of the GDPR.”

The National Law Review here in the US says that the GDPR will apply to US healthcare only in the following circumstances:

• A part of your business is physically located within the EU.
• Your business offers goods or services (even if for free) to individuals in the EU. The offering of goods or services is more than mere access to a website or an email address. It includes, for example, marketing activities intended to recruit individuals in the EU to be patients at a hospital in the United States.
• You electronically monitor the behavior of individuals in the EU. This includes monitoring patients after they return to the EU, for example, as part of post-discharge patient engagement to prevent hospital readmission.

Are US healthcare practices subject to GDPR if a European citizen seeks treatment there while traveling or studying in the US? No, protected health information is not Personal Data under the GDPR merely because it concerns an EU citizen. Instead, the data must concern an individual located in a country covered by the GDPR. The data collected from an EU citizen at a location in the United States will be subject to US law unless the data was solicited from an individual while the individual was physically located in the EU or the organization continues to monitor the EU citizen after the citizen returns to the EU, such as part of post-discharge patient engagement programs.

Would a US practice be subject to GDPR if it transmits patient records to a healthcare provider in Europe for a patient seeking treatment here? Again, no. Practices here must follow US law, but the EU health care provider must protect the individual’s privacy in accordance with GDPR while the individual is in the EU.

Are US practices subject to GDPR if it does not intentionally market to the EU but an EU resident visits its website? No. Here is a good example from the GDPR website in the EU. A man in Paris went on the website for a pizza delivery service in Miami in order to purchase a pizza for a friend who lives in Miami. The Miami restaurant obviously doesn’t deliberately market their services and products in Europe. This would be considered incidental and not deliberate. Thus, the pizza place does not fall under the jurisdiction of the GDPR.

To read the full National Law Review article: https://www.natlawreview.com/article/does-gdpr-regulate-clinical-care-delivery-us-health-care-providers

2. Will the US adopt the same or similar laws as the GDPR?

This is a topic of much debate here in the US. The general belief among the more credible sources is that America has already passed and will continue to pass laws to protect individual’s private information. It is unlikely that those laws passed will be the same as the GDPR. The political and business culture in the US is very different from most of the world.

About the Author/TMC

Debra Gordick is the Mediator/Government Liaison for Total Medical Compliance. TMC is a private consulting company providing affordable programs and seminars for health care providers allowing them to achieve and maintain compliance with government regulations such as HIPAA, OSHA and Infection Control. TMC services include on-site employee training, customized compliance manuals, office inspections, and ongoing client support through monthly newsletters and a fully staffed Call Center. Information on seminar schedules and products can be found on the TMC web site, http://www.TotalMedicalCompliance.com.  For additional information call 888-862-6742 or email Service@totalmedicalcompliance.com.