Artificial Intelligence in Healthcare
Artificial Intelligence

Part 2: Who Regulates Healthcare AI?

Artificial Intelligence & Regulatory Compliance


Written by Joanne Byron, BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS




This article follows Part 1 - Basics of Artificial Intelligence (AI) and Healthcare Compliance published by AIHC on June 6, 2023.  AI is advancing rapidly, so we encourage you to reference the new Artificial Intelligence article category for the latest articles.  As stated in Part 1, the Office of the National Coordinator for Health Information Technology (ONC) and the Agency for Healthcare Research and Quality (AHRQ), with support from the Robert Wood Johnson Foundation, turned to an independent group of scientists and academics to consider how AI might shape the future of public health, community health, and healthcare delivery.  The question remains, how will the use of AI be regulated for health care use?


Artificial Intelligence/Machine Learning has gained heightened attention globally.  Augmented Intelligence has been embraced as a concept by physician organizations to underscore that emerging AI systems are designed to aid humans in clinical decision-making, implementation and administration to scale healthcare, according to Act Online Key Terminology for AI in Health.


Although the United States is making progress in developing domestic AI regulation, including with the National Institute of Standards and Technology (NIST) AI Risk Management Framework, the existing laws and regulations that apply to AI systems is still a work-in-progress.  The goals are to protect people from unsafe or ineffective systems. 


So, Who Regulates Healthcare AI?


What seems like a simple question is really a complex situation.  This article only scratches the surface of various regulatory agencies involved in the regulation of AI.  The Health & Human Services (HHS) response to OMB Memorandum 21-06 “Guidance for Regulation of Artificial Intelligence Applications” was drafted in November 2020 and is directed to the heads of all Executive Branch departments and agencies, including independent regulatory agencies.  Much has happened since then.


On April 25, 2023, the Federal Trade Commission (FTC), the Civil Rights Division of the U.S. Department of Justice (DOJ), the Consumer Financial Protection Bureau (CFPB), and the U.S. Equal Employment Opportunity Commission (EEOC) released a joint statement highlighting their commitment to "vigorously use [their] collective authorities to protect individuals" with respect to artificial intelligence and automated systems (AI), which have the potential to negatively impact civil rights, fair competition, consumer protection, and equal opportunity.


The joint statement from the DOJ, FTC, CFPB, and EEOC signifies a growing awareness and concern among federal agencies about the potential risks and challenges posed by AI and automated systems. As AI continues to become more integrated into all aspects of daily life, the importance of addressing potential biases, transparency issues, and flawed design becomes increasingly critical.


Federal Trade Commission (FTC) Raises Concerns


The FTC’s mission is to protect consumers and competition through preventing anticompetitive, deceptive and unfair business practices.  This is achieved through law enforcement, advocacy, and education without unduly burdening legitimate business activity.  The FTC Act’s prohibition on deceptive or unfair conduct can apply if you make, sell, or use a tool that is effectively designed to deceive – even if that’s not its intended or sole purpose. The FTC’s action should help protect healthcare organizations by limiting deceptive or exaggerated promises of what a medical device or AI software can actually do.  It’s not uncommon for advertisers to say that some new-fangled technology makes their product better – perhaps to justify a higher price or influence labor decisions.


On May 18, 2023, the FTC issued a warning that the increasing use of consumers’ biometric information and related technologies, including those powered by machine learning, raises significant consumer privacy and data security concerns and the potential for bias and discrimination. Biometric information refers to data that depict or describe physical, biological, or behavioral traits, characteristics, or measurements of or relating to an identified or identifiable person’s body.


The Federal Drug Administration & AI


The Food & Drug Administration (FDA) released a discussion paper in 2019 and then an action plan on January 21, 2021 regarding Artificial Intelligence and Machine Learning, or AI/ML.  This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software.  Then, in April 2023, the FDA is publishing a draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions."

  • This draft guidance proposes a science-based approach to ensuring that AI/ML-enabled devices can be safely, effectively, and rapidly modified, updated, and improved in response to new data.

The approach the FDA is proposing in this draft guidance would put safe and effective advancements in the hands of health care providers and users faster, increasing the pace of medical device innovation in the United States and enabling more personalized medicine.

  • This means, for example, that diagnostic devices could be built to adapt to the data and needs of individual health care facilities and that therapeutic devices could be built to learn and adapt to deliver treatments according to individual users' particular characteristics and needs.

National Institute of Standards and Technology (NIST) AI Risk Management Framework


Released on January 26, 2023, NIST’s AI Risk Management Framework or “AI RMF” which is intended to be used voluntarily to improve the ability to incorporate trustworthiness considerations into the design, development, use, and evaluation of AI products, services, and systems.  The Framework was developed through a consensus-driven, open, transparent, and collaborative process with the intention to build on, align with, and support AI risk management efforts by others.


Recently NIST launched the Trustworthy and Responsible AI Resource Center (AIRC), which will facilitate implementation of, and international alignment with, the AI RMF.  We recommend watching the introduction video:  https://www.nist.gov/video/introduction-nist-ai-risk-management-framework-ai-rmf-10-explainer-video


For healthcare HIPAA covered entities, NIST is likely a familiar organization to you.  NIST published prior documents related to AI.  The initial draft of the AI RMF was published March 17, 2022 and a second draft on August 18, 2022.


The Health Insurance Portability and Accountability Act (HIPAA)

Public Law 104-191


The Office for Civil Rights (OCR) is responsible for enforcing the HIPAA Privacy and Security Rules (45 C.F.R. Parts 160 and 164, Subparts A, C, and E). One of the ways that OCR carries out this responsibility is to investigate complaints.  As health care organizations evolve with the use of AI, there is increased potential for cyber criminals to exploit vulnerabilities.


At the present, there are two exclusions existing in the HIPAA Privacy Rule that allow Covered Entities to share Protected Health Information (PHI) with device vendors and other organizations without the authorization of the individual(s) to whom the PHI relates. The two exclusions can be found in 45 CFR §164.512(b)(1) and 45 CFR §164.512(i)(1). Respectively, they relate to:

  • Disclosures to vendors regulated by the Federal Drug Administration are permitted by the Privacy Rule for the “purpose of activities related to the quality, safety or effectiveness of such FDA-regulated product or activity”.   The FDA regulates the sale of all medical device products, including personal health devices that transmit data to AI-driven healthcare solutions as described above.
  • PHI can also be disclosed without authorization for research purposes without being de-identified if the disclosure is approved by an Institutional Review Board or Privacy Board. In such circumstances, the disclosed PHI must remain in the possession of the Covered Entity and the disclosure(s) can only be for the purpose of preparatory research (i.e., programming a “Supervised Learning Algorithm”).


Conclusion


Simply stated, a shift to AI calls for new skills.  It warrants increased knowledge of HIPAA privacy, security and anticipating other legal issues surrounding it’s use in healthcare.


Needless to say, it is important to maintain a robust HIPAA program and utilize information from the National Institute of Standards and Technology (NIST) AI Risk Management Framework as mentioned above.


In the context of HIPAA, healthcare data, and AI technologies, AI developers and vendors should consider that HIPAA only provides a federal floor of privacy and security standards. Often, other state and federal laws can apply that pre-empt HIPAA – particularly with regard to healthcare adjacent data – or apply to more organizations than Covered Entities and Business Associates.  Also, many Managed Service Providers (MSP) companies providing services to healthcare organizations should be aware of AI applications and security vulnerabilities.


If your organization plans or is using AI for medical diagnostics, reference the annual joint publication by the U.S. Government Accountability Office (GAO) and the National Academy of Medicine published each September entitled “Technology Assessment – Artificial Intelligence in Health Care – Benefits and Challenges of Machine Learning Technologies for Medical Diagnostics”.   A new publication is posted each year: https://www.gao.gov/products/gao-22-104629


AIHC will continue to post articles related to artificial intelligence with regards to healthcare compliance.  Click Here for additional articles on various HIPAA topics.  Click Here for articles relating to Artificial Intelligence. Visit the AIHC Certifications page with online compliance learning opportunities.

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Auditing, Managing Denials Is Important to Good A/R Hygiene
Auditing

Compliance & Internal Investigations

Written by: Joanne Byron, BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS




Are you an internal auditor conducting “routine” reviews? Have you ever uncovered erroneous or potentially fraudulent evidence? Once your suspicions have been reported to the Compliance Officer, were you asked to partake in evidence gathering during the investigation? The content of this article is for educational purposes and not intended as consulting or legal advice.


For those of you more experienced auditors, additional training in how to handle evidence during an internal investigation not only advances your career but helps secure evidence that can be used if an actual crime has been committed. I also recommend reading When Healthcare White-Collar Crimes Turn Red, an AIHC blog article from 2021.


Do you need to convince executives that crime is a potential problem for your organization? The Department of Justice (DOJ) posts “News & Noteworthy” cases here. 


What Comes to Mind When You Hear the Word “Forensic”?

 

Most of us think about investigations as seen on television programs, such as “CSI” or “Bones.” Forensic science is a critical element of the criminal justice system – “Forensic scientists examine and analyze evidence from crime scenes and elsewhere to develop objective findings that can assist in the investigation and prosecution of perpetrators of crime or absolve an innocent person from suspicion.”


According to the Merriam-Webster dictionary, the word forensic is defined as the following:

  • Belonging to, used in, or suitable to courts of judicature or to public discussion and debate
  • Relating to or dealing with the application of scientific knowledge to legal problems

Your auditing and compliance skills become valuable to professional law enforcement, but you need to know what, when and how to handle a situation which could potentially turn into criminal charges against someone within your organization. First, let’s start with prevention.


Is It an Internal or External Investigation?


Internal Investigations are conducted by skilled employees (or a consultant under contract working for the organization) trained to perform specialized audits to gather evidence when there is suspected fraud, abuse or crime. These investigations are typically conducted to gather information sufficient for legal counsel to determine whether an external investigation is warranted by the appropriate authorities.  These employees are often referred to as Internal Forensic Auditors or Internal Investigators. For the purpose of this course, we will refer to this position as an Internal Forensic Auditor.


Internal Forensic Auditors report to a Board of Directors, Compliance Officer and/or Audit Committee of the health care organization and typically work under the direction of the organization’s legal counsel.


External Forensic Auditors are independent of the organization they are auditing. They are experts working as an investigator for an accounting or consulting firm, CMS, a police department, the FBI or another agency as described above.


The process of conducting a forensic investigation is, in many ways, similar to the process of conducting an audit, but with some additional considerations. The various stages are briefly described below. 


Step 1: Accepting the Investigation


Review information regarding the matter and consider whether you (and your team) have the necessary skills and experience to accept the work.

  • Forensic investigations are specialized in nature, and the work requires detailed knowledge of fraud investigation techniques and the legal framework.
  • Investigators must also have received training in interview and interrogation techniques and in how to maintain the safe custody of evidence gathered.
  • Investigators must be able to address potential conflicts of interest or bias and achieve objectivity.

Step 2: Planning the Investigation


The investigating team must carefully consider what they have been asked to achieve and plan their work accordingly. The objectives of the investigation will include:

  • Recognize if there is sufficient evidence to warrant a forensic investigation. If so, then anticipate planning required to achieve the following:

      o Identify the type of fraud that has been operating, how long it has been operating for,
    and how the fraud has been concealed;

           Determine deadlines and timeframes to complete the investigation which may
    be driven by regulatory factors;

      o Identify the fraudster(s) involved;

      o Quantify the financial loss suffered by the organization;

      o Gather evidence for potential use in court proceedings;

           Identify the type of report format required and record evidence appropriately; and

      o Provide advice to prevent the reoccurrence of the fraud. 

The investigators should also consider the best way to gather evidence. They may choose the use of computer assisted audit techniques or other various methods appropriate for the situation.


Step 3:  Gathering Evidence – Fact Finding


In order to gather detailed evidence, the investigator must understand the specific type of fraud that is suspected. The evidence should be sufficient to ultimately prove the identity of the fraudster(s), the mechanics of the fraud scheme, and the amount of damage or loss suffered by the organization.


It is important that the investigating team is skilled in collecting evidence that can be used in a court case and in keeping a clear and secure chain of custody until the evidence is presented in court. If any evidence is inconclusive, or there are gaps in the chain of custody, then the evidence may be challenged in court or even become inadmissible. Investigators must be alert to documents being falsified, damaged or destroyed by the suspect(s). 


“Chain of custody” is defined by Dictionary.com as “the order in which a piece of criminal evidence should be handled by persons investigating a case, specifically, the unbroken trail of accountability that ensures the physical security of samples, data and records in a criminal investigation.” To prove the chain of custody, and ultimately show that the evidence has remained intact, prosecutors generally need internal investigators who can testify:

  • That the evidence offered in court is the same evidence they collected or received.
  • To the time and date the evidence was received or transferred to another provider.
  • That there was no tampering with the item while it was in custody.

Evidence can be gathered using various techniques, including: 

  • Testing controls to gather evidence which identifies the weaknesses which allowed the fraud to be perpetrated;
  • Using analytical procedures to compare trends over time or to provide comparatives between different segments of the business;
  • Applying computer assisted audit techniques which may help to identify the timing and location of relevant details being altered in the computer system;
  • Discussions and interviews with employees;
  • Substantive techniques such as: reconciliations, cash counts and reviews of documentation.

Step 4: Analyzing Data


After evidence and facts have been gathered and recorded, it is time to analyze all the data. The goal of data analysis is to determine if there is a relationship between the independent and dependent variables and to look for patterns within the data. 


Recording and organizing data may take different forms depending on the kind of information being collected. The way you collect your data should relate to how you’re planning to analyze and use it. Regardless of what method you decide to use, recording should be done concurrently with data collection if possible, or soon afterwards, so that nothing gets lost and memory doesn’t fade. Some of the things to do with the information collected can include:

  • Gather together information from all sources and observations;
  • Make photocopies of all recording forms, records, audio or video recordings, and any other collected materials to guard against loss, accidental erasure, or other problems;
  • Enter narratives, numbers, and other information into a computer program where they can be arranged and/or worked on in various ways;
  • Perform any mathematical or similar operations needed to get quantitative information ready for analysis;
      o These could include entering numerical observations into a chart, table, or spreadsheet, or figuring the mean (average), median (midpoint), and/or mode (most frequently occurring) of a set of numbers.
  • Transcribe (making an exact, word-for-word text version of) the contents of audio or video
    recordings;
  • Code data (translating data), particularly qualitative data that isn’t expressed in numbers, into a form that allows it to be processed by a specific software program or subjected to statistical analysis; and
  • Organize data in ways that make it easier to work with. This will depend on your research design and your evaluation questions.
      o Consider grouping observations by the dependent variable (indicator of success) they
    relate to, by individuals or groups of participants, by time, by activity, etc.
      o You might also want to group observations in several different ways so that you can study interactions among different variables. 

There are two kinds of data you’re apt to be working with. However, not all evaluations will necessarily include both.

  • Quantitative data refers to the information that is collected as, or can be translated into, numbers which can then be displayed and analyzed mathematically.
  • Qualitative data can be collected as descriptions, anecdotes, opinions, quotes, interpretations, etc. They are generally not able to be reduced to numbers and/or are considered more valuable or informative if left as narratives.

As you might expect, quantitative and qualitative information need to be analyzed differently. The investigation is likely to lead to legal proceedings against one or several suspects. Therefore, members of the investigative team must be comfortable with appearing in court to explain how the investigation was conducted and how the evidence was gathered.


Step 5: Report Your Findings


Draft the report in an objective manner. Do not draw conclusions, just report the facts. The checklist below summarizes what a typical report should contain:

  • Provide a Summary of the Investigation or Case
  • Describe the Investigation Plan
  • Case Notes – Keep an Investigator Diary
  • Information Interview Summaries
  • Interview Reports
  • Analysis of Investigation
  • Conclusion
  • Recommendations and Additional Action(s) Required With This Case
  • Exhibit Listing - attachments and evidence related to the case

Conclusion


An Ounce of Prevention Is Worth a Pound of Cure – So Learn More About Health Care Crime


A little precaution before a crisis occurs is preferable to a lot of legal complications, “bad press” and huge potential losses afterward. Preventing fraud in your organization starts with not hiring criminals! That might sound ridiculous, but are we really doing everything we should during the hiring phase of employees and contractors?


Most organizations are using the LEIE on the OIG website to screen new hires and conduct monthly verifications. But is this enough?


Unverified employees can put your organization at risk with a dramatic impact on your company’s brand reputation, performance and finances. Screening employees at hire, and periodically during employment, is a must for creating a safe workplace.


Below is a “short list” of screening tactics to consider before extending an offer to a candidate for hire. Be sure to review your procedure with legal counsel or a human resources expert to avoid any potential legal consequences with the U.S. Equal Employment Opportunity Commission (EEOC) related to changing your current hiring practices.

  • Criminal background check
  • Office of Inspector General (OIG) Exclusions Database check
  • Education – verify graduation, degree
  • Professional Certifications (check all certifications with the certifying agency – do not accept certificates from the potential employee as proof)

The EEOC has a webpage dedicated to help employers that addresses “Background Checks – What Employers Need to Know.” The information on this page is a joint publication between the EEOC and the Federal Trade Commission or FTC.


When making personnel decisions, which include hiring, retention, promotion, and reassignment, the EEOC states that employers should consider the background of applicants and employees. For example, the EEOC states you may want to consider verifying:

Except for certain restrictions related to medical and genetic information (per HIPAA, addressed further on the EEOC website), it's not illegal for an employer to ask questions about an applicant's or employee's background or to require a background check.


AIHC offers training – a “how to” participate in or conduct an internal investigation. The course is offered online with the option to certify (with a professional proctor online). The program is entitled Internal Forensic Auditor. If this course seems too intense, you may want to begin with the Auditing for Compliance online program.

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Telehealth
HIPAA, Telehealth

Audio-Video Telehealth, Mobile Device Management & You

Written by: Joanne Byron, BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS


This article addresses how to track telehealth policies while addressing HIPAA compliance and mobile device management as the United States enters into a post-pandemic era. The information is an overview and should not be used as legal or consulting advice. Health care providers need to look toward long-term telehealth policies, ensure compliance and realize there is remaining work to be done. 


Scroll to the end of this article for “Basic Telehealth Terminology” if you are new to telehealth or if you are a mobile device app developer!


Most Providers Utilize Audio-Only Telehealth


More than two-thirds of providers utilizing telehealth use audio-only, according to a recent Telehealth Survey conducted November 2021 through December 2021 by the American Medical Association (AMA). According to this survey, 85% of physician respondents indicate they currently use telehealth. Those reporting a decrease in use since first offering it, now indicate doing a mix of in-person and virtual care. Of physician’s using telehealth, the trend indicates 93% are conducting live, interactive video visits with patients and 69% are doing audio-only visits.  


Considering this survey and other reports on audio-video services, concerns seem to focus on potential overutilization, equity and quality of care. 


A concern expressed to AIHC, by our Compliance and HIPAA Officer members, surrounds mobile devices used by providers and practice managers and the organization’s responsibility to comply with applicable rules, regulations and mobile device policies.


So, how do policies apply? 

 

If your providers use a mobile device to access an organization’s internal network or system, the owner of that network or system’s policies and procedures apply to your use of the mobile device to gain such access. It is your organization’s responsibility to understand and follow the organization’s policies and procedures.


If an organization allows providers and professionals to use mobile devices for work, the organization should have reasonable and appropriate mobile device policies and procedures. The policies and procedures should describe any configuration requirements for mobile devices used by providers and professionals for work. It is your responsibility to understand and follow your organization’s mobile device policies and procedures. But, what about using personally owned mobile devices for work?

  • "Bring Your Own Device" or BYOD refers to using a personally owned mobile device for work. Providers should be reminded to let their organization know when they want to use a personally owned mobile device. Many organizations have centralized security management to make sure mobile devices accessing their internal networks or resources are compliant with their security policies. Centralized security management includes:

o Configuration requirements, such as installing remote disabling on all mobile devices; and


o Management practices, such as setting policy for individual users or a class of users on specific mobile devices.


It is the provider’s responsibility to understand and follow the organization’s mobile device policies and procedures. Registering the provider’s mobile device with the organization allows the organization to control who has access to its network or system and will keep unauthorized persons from accessing its network or systems.

  • Registering these mobile devices with your organization may also help the organization or law enforcement find your mobile device if it is lost or stolen. Providers should be directed to contact their organization’s Privacy Officer or Security Officer to register their mobile device.

Utilizing Step 4 from ONC’s 5-Step Process to Manage Mobile Devices Used by Health Care Providers & Professionals, the list of questions below is a way to take inventory of potential safeguards needed to address risk areas.


Mobile Device Management


 If your organization allows the use of mobile devices, what should the organization do about managing the use of mobile devices?


   o Has the organization identified all the mobile devices that are being used in the organization? How is the organization keeping track of them?


   o Has the organization assigned responsibility to check all mobile devices used for remote access, to find out if selected security/configuration settings are enabled?


   o Should there be a regular review and audit of the mobile devices? 


Misuse of Mobile Devices


 Does the organization have written procedures for addressing misuse of mobile devices?


   o If so, what are the consequences when a mobile device is misused and the incident poses risk of a data breach?


Should the Organization Allow BYOD?


 Is this a policy already in place, where providers are using their own devices?


   o Should the organization let providers and professionals use their personally owned mobile devices within the organization?


 Should providers and professionals be able to connect to the organization’s internal network or system with their personally owned mobile devices, either remotely or on site?


Restrictions on Mobile Device Use


 Does the organization restrict how providers and professionals can use mobile devices?


   o Can providers and professionals use mobile devices to access internal networks or systems, such as an EHR?


   o Are providers and professionals restricted from using mobile devices when they are away from the organization?


   o Can providers and professionals take their mobile devices home?


   o Should the organization allow texting or emailing of health information?


      Is there encryption allowing compliant texting and emailing from the mobile device?


Security/Configuration Settings for Mobile Devices


 Will the organization institute standard configuration and technical controls on all mobile devices used to access internal networks or systems, such as an EHR?


   o If so, is the organization's current mobile device configuration document, including connections to other systems/applications, inside and outside of the firewall.


Information Storage on Mobile Devices


 Are there restrictions on the type of information providers and professionals can store on mobile devices?


   o If so, where and for how long should the data be stored?


 Are providers and professionals allowed to download mobile applications to mobile devices? If so, what type(s) of applications are approved?


Recovery/Deactivation of Mobile Devices


 Does the organization have procedures to wipe or disable a mobile device that is lost or stolen?


 Does the organization have standard procedures to recover mobile devices from providers and professionals when their employment or association with the organization ends?


Mobile Device Training


Training is always a challenge, but if your organization cannot achieve effective training and compliance, you may need to reconsider how telehealth is delivered to your patient population.


 How is the organization training its workforce (management, doctors, nurses, and staff) on policies and procedures?


 How does the organization hold its workforce (management, doctors, nurses, and staff) accountable for non-compliance? 


What Additional Information Should I Know for Compliance?


Covered entities must comply with HIPAA Privacy and Security Rules to protect and secure health information, even when using mobile devices as described above. Taking it a step further, health care leaders are responsible to ensure that mobile device procedures and policies have been developed and properly implemented to protect the health information patients entrust to you.


Make Tracking Audio-Only Policy Easy


A great resource is utilizing the National Telehealth Policy Resource Center called “CCHP,” short for Center for Connected Health Policy. CCHP has been tracking audio-only policies across the country and offers access to state audio-only policies via CCHP’s Policy Finder Tool.


As AIHC advises, another resource is legal advice through your malpractice insurance company. At no additional charge, a risk attorney can be made available to help review which policies impact your type of practice and organization.


Free HIPAA Compliance Resources


Another reliable resource is found at HealthIT.gov, the official website of the Office of the National Coordinator for Health Information Technology, otherwise known as “ONC.” ONC offers basic guidance in these five steps 1) Decide; 2) Assess; 3) Identify; 4) Develop, Document and Implement; and 5) Train entitled “five steps organizations can take to manage mobile devices used by health care providers and professionals.”


Does Your Organization Have a Trained (Certified) HIPAA Privacy/Security Officer?


Your HIPAA Compliance Officer can serve as the best resource to help your organization navigate the telehealth and mobile device compliance issues facing your providers today. AIHC offers an online course covering both privacy and security with the option of certification (proctored and administered online).  The cost of certification is covered in the tuition price. Learn more.


It is highly recommended that mobile health app developers and Managed Service Providers (MSPs) have an in-house HIPAA Compliance Officer contributing input to ensure technology is compliant.


Are You a Mobile Health App Developer?


Integrating protections into your technology to create HIPAA compliant products is necessary for your company to succeed. Health care providers are subject to the HIPAA rules as covered entities to protect identifiable health information when it is created, received, maintained and/or transmitted. These protections are required under Federal and State Privacy, Security and Breach Notification Rules. A few basic resources to reference are:


The Office for Civil Rights (OCR) HIPAA website devotes a webpage under Special Topics entitled “Resources for Mobile Health Apps Developers.”


The Federal Trade Commission (FTC) offers a webpage entitled “Mobile Health Apps Interactive Tool” to help you locate federal laws to follow.


For Beginners - Basic Telehealth Concepts


Telehealth is also referred to as Telemedicine. It is the use of telecommunications technology to provide health care services to persons who are at some distance from the provider. This type of patient encounter involves a spectrum of technologies.


Coverage and payment for telehealth can include consultation, office visits, individual psychotherapy, pharmacologic management and other services delivered via an interactive audio and video telecommunications system.  

  • Providers are located at the distant site; and
  • Patients are located at the originating site.

Provider at the distant site - As stated above, providers are at the “distant site,” referring to where the provider is at time of service. The provider can communicate with the patient using an interactive audio and video telecommunication system that permits real-time communication with the beneficiary.


When telehealth is used, it is considered to be rendered at the physical location of the patient, and therefore a provider typically needs to be licensed in the patient’s state. During the COVID-19 public health emergency (PHE), many states waived this requirement or provided specific exceptions. Click Here for Cross-State Licensing information.


Medicaid programs often restrict the type of providers that can be reimbursed when delivering services via telehealth. During the COVID-19 PHE, the list of providers in Medicare and many state Medicaid programs expanded to include professionals such as occupational and physical therapists and speech-language pathologists. Federally Qualified Healthcare Centers (FQHCs) and Rural Health Clinics (RHCs) were also allowed to provide services in some cases. These policies are temporary and most will expire at the end of the PHE.


I also recommend utilizing the TELEHEALTH.HHS.GOV website for providers – “Getting Started with Telehealth.” This webpage provides many additional links to more resources your organization can use to navigate this complex topic.


Temporary telehealth policies during the PHE were implemented to provide improved access to health care during the COVID-19 pandemic. The federal government has been encouraging providers to use telehealth to conduct virtual appointments and has made the telehealth “rules” more flexible. For instance, audio-only delivery of care has rarely been reimbursed historically. But due to COVID and the PHE, temporary policies allow this modality to deliver some services.


The PHE is reviewed and potentially extended every 90 days. When the PHE ends, coverage for telehealth may change. Monitor these updates by using the CCPH website referenced earlier in this article found at https://www.cchpca.org/.

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HIPAA Compliance
HIPAA

Important Update: FTC Clarifies Health Breach Notification Rule- Healthcare Apps and Vendors Are Included

Written by: Susan Walberg, JD MPA CHC




As I have written in previous articles about HIPAA and health-tech, many apps in the marketplace have been largely unregulated with respect to the privacy and security of healthcare data. In order for healthcare-related apps to be regulated, for the most part they needed to be covered under HIPAA. As a result, only the apps that were directly related to providing or billing for healthcare services, or those companies’ ‘Business Associates,’ were required to put specific controls and notifications in place. All the rest were not. The Federal Trade Commission (FTC), the agency responsible for consumer protection, hasn’t really been on the radar in terms of regulatory oversight in this arena.


The many thousands of apps that are selected and used by consumers to manage illnesses, track fitness, and other health-related services do not fall under HIPAA’s requirements and were, for the most part, unregulated. All of this has changed with a September 15, 2021, Policy Statement by the FTC.


According to the Statement, the Health Breach Notification Rule "Helps to ensure that entities who are not covered by the Health Insurance Portability and Accountability Act (“HIPAA”) nevertheless face accountability when consumers’ sensitive health information is compromised.” The Breach Notification Rule is not new, but this clarification is, and signals likely enforcement of a rule that has largely gone unenforced to date. The push to regulate apps came from Congress, and further legislation is likely.


Who is Affected?


The FTC clarifies that vendors of ‘personal health records (PHRs) and PHR-related entities’ have to follow the breach notification procedures outlined in the Rule, which includes notification of consumers, the FTC, and even the media in some cases. These are not HIPAA ‘Covered Entities.’


The Rule covers vendors of PHRs that contain individually identifiable health information ‘created or received by health care providers.’ More specifically, PHRs are defined as an electronic record of “identifiable health information on an individual that can be drawn from multiple sources and that is managed, shared, and controlled by or primarily for the individual.”


The part that may be misunderstood is who the FTC considers a ‘health care provider.’ The FTC considers the developer of a health app or connected device as a ‘health care provider’ because it “furnishes healthcare services or supplies.”


According to the recent Statement, and the definition itself, the rule applies to any app that is capable of drawing information from multiple sources, such as from a consumer and an application programming interface (API). What are some examples? The FTC cites a blood sugar monitoring app that gets information entered by the consumer but also accesses data from the phone, such as the calendar. So all those apps that were previously considered exempt, such as fitness trackers, now need to take note.


What is a Breach?


The second critical aspect of the Statement pertains to what constitutes a breach. While most people consider a breach to be an intrusion, ransomware, or an attack by a hacker, the FTC takes a broader view. Now, it has been clarified, a breach includes unauthorized access, including sharing of information without an individual’s authorization. This is potentially a very big deal for all those apps that fell outside of HIPAA and were not hesitant about sharing consumer data with advertisers, investor-companies, or ‘big tech,’ where such data is often used to build user profiles. If you read my previous article on this topic, it hasn’t been illegal to sell or share consumer information that consumers voluntarily enter into many healthcare apps (unless they fit within HIPAA). Those activities, if not authorized by the consumer, are considered a breach and the FTC has put everyone on notice that more active enforcement of this rule can be expected.  And the penalties? Penalties can be up to $43,792 per violation.


What to Do?


If you are an app developer or own a company involved in developing healthcare apps, you need to review the policies, consumer consent and authorizations, and the technical controls in place. Evaluate where you share consumer data. Look at any data sharing agreements and contracts where sharing data might be part of the deal.


Make sure you review the various rules and regulations that apply to you as well as the various guidance put out by the FTC.  You can find their guidance, enforcement activities, and press releases on their website, ftc.gov. If you’re not sure, get help in figuring out which laws and regulations apply to your organization.


Take note that this area of compliance and enforcement is changing rapidly. Technology got ahead of regulations, especially with changing needs due to COVID.  Check out my website at https://www.susanwalberg.com/

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