Recent Publications - Health Services


‘Made in the USA’ Claims: Handle With Care
May 15, 2018 | Marc S. Ullman | Compliance Investigations & White Collar
Marc Ullman published an article in Natural Products Insider entitled, “‘Made in the USA’ Claims: Handle With Care.” The article focuses on how the Federal Trade Commission has increased its enforcement of its “Made in the USA” standards, which states “all or virtually all” of a product must be made/produced in the United States. Click …
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OIG Report Highlights Telehealth Reimbursement Challenges
May 10, 2018 | Geoffrey R. Kaiser | Jonathan D. Salm | Health Services | Compliance Investigations & White Collar
The utilization of telehealth has flourished over the last decade as innovative technologies and new Medicare regulations have fueled telehealth’s growth. Between 2001 and 2015, Medicare telehealth spending increased by nearly 300% as a result of this boom. However, as the utilization of telehealth services has surged, so have the compliance issues associated with these …
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Cyber Insurance: Protection for the New Normal
May 9, 2018 | Shari Claire Lewis | Ada Kozicz | Privacy, Data & Cyber Law
Cybersecurity breaches have become commonplace. In 2017, the global economy incurred an estimated loss of over $450 billion for cyber-related crimes and security breaches. It is no longer a question of whether a business will fall victim to a security breach or malware attack, but only a question of when.  A cybersecurity event can have …
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Shapiro and Ullman Author Article in Vitamin Retailer
May 1, 2018 | Health Services
Steven Shapiro and Marc Ullman co-wrote an article published in the May 2018 issue of Vitamin Retailer, the dietary supplement industry’s leading magazine. The article focuses on the popular new dietary supplement, Kratom, its potentially hazardous effects and how the FDA is actively monitoring it. Click here to read the article. …
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OIG Report Reminds PT Service Providers to Review Billing Practices
April 16, 2018 | Geoffrey R. Kaiser | Ada Kozicz | Health Services | Compliance Investigations & White Collar
A recent report issued by the U.S. Department of Health and Human Services, Office of Inspector General (OIG), estimates that 61% of claims submitted to Medicare for outpatient physical therapy (PT) services failed to comply with Medicare requirements. The OIG report serves as a reminder to PT providers about the importance of accurate billing and …
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Warning from DoH: HIPAA Compliance Doesn’t End When a Business Closes
March 19, 2018 | Benjamin P. Malerba | Ada Kozicz | Health Services
A recent settlement between the U.S. Department of Health and Human Services, Office of Civil Rights (the Department) and Filefax, Inc. serves as a stark reminder for covered entities and business associates that their obligation to comply with the Health Insurance Portability and Accountability Act (HIPAA) does not end simply because they close their business …
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Kaiser Published in Westlaw Journal
March 16, 2018 | Geoffrey R. Kaiser | Compliance Investigations & White Collar
Geoffrey R. Kaiser’s article, “Government Dismissal under the False Claims Act: Policy Change or Much Ado About Nothing?” was published in Westlaw Journal White Collar Crime in the March 2018 issue. Click here to read the article. …
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Exploring Limits Of Anti-Kickback Law Employee Safe Harbor
March 5, 2018 | Geoffrey R. Kaiser | Health Services | Compliance Investigations & White Collar
The federal Anti-Kickback Statute contains a statutory exception or “safe harbor” providing that the AKS will not apply to “any amount paid by an employer to an employee (who has a bona fide employment relationship with such employer) for employment in the provision of covered items or services.” 42 U.S.C. 1320a-7b(b)(3)(B) (emphasis added). Similarly, the parallel regulatory exception states …
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2018 Bipartisan Budget Act and Stark Law Amendments
February 21, 2018 | Geoffrey R. Kaiser | Jonathan D. Salm | Compliance Investigations & White Collar | Health Services
On February 9, 2018, Congress passed the Bipartisan Budget Act of 2018, providing a two-year budget agreement that increases federal spending, funds disaster relief efforts, and amends a number of healthcare programs, among a host of other changes. While the Act has broad implications for many aspects of U.S. law, one amendment in particular should …
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New York Extends Time to File Malpractice Claim
February 21, 2018 | Ada Kozicz | David E. Richman | Health Services | Medical Malpractice Defense
Governor Andrew Cuomo has signed a new law, known as “Lavern’s Law,” that extends the amount of time a patient has to file a medical malpractice claim for a missed cancer or malignant tumor diagnosis. Patients now have 2 1/2 years to file a claim from the date the misdiagnosis is discovered by the patient, …
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CMS Updates Its Position on Texting Patient Information
January 11, 2018 | Health Services
Recognizing that texting has become a valuable and essential means of communication among providers, the Centers for Medicare and Medicaid Services (CMS) recently issued new guidance regarding its position on texting of patient information. The guidance clarifies that texting patient information may be permissible if certain security standards are met, but it also distinguishes between …
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The Status of Telemedicine Reimbursement
December 20, 2017 | Benjamin P. Malerba | David E. Richman | Ada Kozicz | Health Services
Benjamin Malerba, David Richman and Ada Kozicz wrote an article published in Health eSource, a publication of the American Bar Association’s Health Law Section entitled, “The Status of Telemedicine Reimbursement: States’ Efforts to Incentivize Providers to Utilize Telehealth Technologies.” The article centers on the importance of creating legislation that will provide insurance reimbursement for telemedicine, as a means to …
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Year-End Deadline for NY Medicaid Providers and Third-Party Billers
December 13, 2017 | Benjamin P. Malerba | Ada Kozicz | Health Services
New York State Medicaid providers who claim, order or receive at least $500,000 from the Medicaid Program in any consecutive 12-month period have until December 31 to certify that they have implemented a compliance program aimed at detecting and preventing Medicaid fraud, waste and abuse. This requirement also applies to third-party billing companies that bill …
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Substance Use Providers Beware: New Patient Record Release Requirements
December 13, 2017 | Carol A. Hyde | Ashley S. Osadon | Health Services
Substance use treatment providers and rehabilitation centers should use caution when reviewing and approving written consents for the disclosure of substance use patient records, specifically consents authorizing disclosure to government agencies, as such requests frequently do not comply with new SAMHSA regulations. On January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) …
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Deadline Fast-Approaching for Medicaid Managed Care Participating Providers
November 7, 2017 | Geoffrey R. Kaiser | Ashley S. Osadon | Health Services | Compliance Investigations & White Collar
The deadline for required enrollment with Medicaid under the Federal 21st Century Cures Act (Cures Act) is fast approaching. Currently, Medicaid Managed Care providers are sending mass mailings to their participating providers with notices of required compliance. By December 1, 2017 certain participating healthcare providers of New York State Medicaid Managed Care plans or the …
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OIG Audit Discovers $51.6 M in Overpayments to Acute-Care Hospitals
October 17, 2017 | Geoffrey R. Kaiser | Jonathan D. Salm | Health Services | Compliance Investigations & White Collar
The Office of the Inspector General of the Department of Health and Human Services (OIG) issued a report last month regarding inappropriate payments made to acute-care hospitals for outpatient services provided to Medicare beneficiaries who were inpatients of other facilities. OIG’s findings highlight the need to diligently review claims before submitting them to Medicare. In …
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New York Legislature Broadens Telehealth Services Coverage for Adult Care Facilities
October 16, 2017 | Health Services | Privacy, Data & Cyber Law
New York continues to drive legislative reform to promote telehealth services – clinical healthcare provided remotely through information technology. Most recently the state legislature passed a bill that expands the definition of “originating sites” where telehealth services may be provided to Medicaid patients in an effort to lower costs and health risks. For background, in …
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OMIG Issues New Compliance Alert for NY Medicaid Program
October 13, 2017 | Health Services | Compliance Investigations & White Collar
A recent Compliance Alert published by the New York State Office of Medicaid Inspector General (OMIG) underscores the need for Medicaid providers to re-evaluate their compliance programs in light of a shift toward new payment methodologies. On August 31, OMIG published its first Compliance Alert of 2017, entitled “Mandatory Compliance Programs’ Risk Assessments: Changes in …
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Shapiro Publishes Article in Natural Products Insider
September 14, 2017 | Steven Shapiro | Health Services | Compliance Investigations & White Collar
Steven Shapiro has published an article in Natural Products Insider entitled, “A Legal Look at the Definition of ‘Clean Label’.” Click here to read the article. …
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NY Appellate Division, Third Dept., Rules EO-38 Soft Cap Unconstitutional
August 10, 2017 | Jeffrey P. Rust | Ashley S. Osadon | Health Services
On June 22, 2017, a New York appeals court took aim at Gov. Andrew Cuomo’s Executive Order No. 38. The executive order and the accompanying Department of Health (“DOH”) regulations have been the subject of controversy and appeal since their 2012 debut. The New York State Appellate Division, Third Department, in Leadingage N.Y., Inc. v. …
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OIG Clarifies Hospitals’ Obligations to Patients with Psychiatric Emergencies
August 9, 2017 | Benjamin P. Malerba | Ada Kozicz | Health Services
The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) recently entered into a settlement with AnMed Health (“AnMed”), a South Carolina hospital, for over $1.2 million for a violation of the Emergency Medical Treatment and Labor Act (“EMTALA”). The settlement serves as an important reminder and clarification on the obligations imposed …
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NY’s Highest Court Hears Arguments on Physician-Assisted Suicide
July 21, 2017 | Benjamin P. Malerba | Ada Kozicz | Health Services
The New York Court of Appeals recently heard arguments in the Myers v. Schneiderman lawsuit, which challenges the legality of physician assisted suicide and whether a patient should have the right to choose a peaceful death on his or her own terms. As the law currently stands, New York Penal Law Section 125.15 prohibits physician-assisted …
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.health Domain Name Now Available for Trademark Holders
June 8, 2017 | Health Services
Dothealth LLC, the company that operates the official registry for the .health domain name, has announced the first phase of .health’s public launch. During this initial “Sunrise Phase” trademark owners that are registered with ICANN’s Trademark Clearinghouse will have the first opportunity to register for the new domain name. This phase is open now through …
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‘Careless’ Disclosure of Sensitive Information Leads to HIPAA Settlement
June 8, 2017 | Health Services
The U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that St. Luke’s-Roosevelt Hospital Center Inc. (“St. Luke’s”) entered into a HIPAA settlement for $387,200 resulting from the impermissible disclosure of two patients’ protected health information (“PHI”). In addition to the settlement, St. Luke’s has entered into a specific Corrective Action Plan. …
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Hidden Risks In Practice Acquisitions And Joint Ventures
May 25, 2017 | Health Services | Complex Torts & Product Liability
There is a potential compliance “blind spot” associated with what many in the healthcare industry would regard as ordinary practice acquisitions and joint ventures involving hospitals and other provider organizations. This area of possible vulnerability arises from the payment of consideration for what are sometimes insufficiently delineated assets of the target or partner entity. If …
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Do Your Contracts Inadvertently Waive the Right to Exemplary Damages and Attorney Fees for Disclosure of Trade Secrets?
May 15, 2017 | Health Services
On May 11, 2016, the Defend Trade Secrets Act of 2016 (“DTSA”) was signed into law, which includes a lesser-known provision affecting the rights and remedies of employers, including hospitals, health systems and private practices, seeking to protect their trade secrets and confidential information. In part, the DTSA (18 USC §1833) provides Federal and State …
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OMIG Releases Work Plan for 2017-2018
May 15, 2017 | Health Services
The New York State Office of Inspector General (“OMIG”) has released its Work Plan for its new fiscal year, April 1, 2017 – March 31, 2018. The Work Plan summarizes new and ongoing activities OMIG will prioritize in the upcoming year, all of which aim to achieve three over-arching objectives: (i) enhance provider compliance; (ii) …
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Shapiro Quoted in Natural Products Insider
May 15, 2017 | Health Services
Steven Shapiro was quoted in a Natural Products Insider article entitled, “Dietary Supplement Industry Blasts N.Y. Labeling Legislation.” In the article, Steven and other industry professionals weigh in on Assembly Bill 7607 which would require a dietary supplement in package form to bear a label containing the name and address of the manufacturer, distributor and …
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UK Health System Infected by Ransomware
May 12, 2017 | Health Services | Privacy, Data & Cyber Law
In a cautionary tale for all companies, but especially healthcare organizations, on May 12, 2017, multiple news sources reported that a broad cyberattack using ransomware caused substantial interference with critical systems across Europe, Russia and Asia. (See e.g., New York Times, BBC News and Silicon Angle.) According to the New York Times, the  attacks were …
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Digital Health Vendors Beware – OCR Continues Aggressive HIPAA Enforcement
May 12, 2017 | Health Services
The US Department of Health and Human Services, Office for Civil Rights (“OCR”) recently announced that CardioNet, Inc., a cardiac monitoring services company, entered into a HIPAA settlement for $2.5 million resulting from the impermissible disclosure of unsecured electronic protected health information (“ePHI”). In addition to the settlement, CardioNet is required to engage in a …
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NY Continues to Increase Access to Medical Marijuana
April 18, 2017 | Health Services
Under New York’s medical marijuana program, which is tightly regulated by the New York Department of Health (“DOH”), patients with serious medical conditions can become certified for use of medical marijuana under the supervision of a licensed healthcare provider. As of March 2017, DOH added two enhancements to the program to increase patient access. First, …
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OIG Releases Compliance Program Update
April 18, 2017 | Health Services | Compliance Investigations & White Collar
On March 27, 2017, the U.S. Office of Inspector General (“OIG”) released a new compliance program guide, Measuring Compliance Program Effectiveness—A Resource Guide (the “Guide”). The Guide was developed by compliance professionals and staff from the U.S. Department of Health and Human Services and OIG, as an effort to help healthcare organizations measure the effectiveness …
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Trump Administration Issues New Regulations for Affordable Care Act Insurance Marketplaces
March 10, 2017 | Health Services
On February 17th, the Department of Health and Human Services (“HHS”) released proposed new regulations aimed at stabilizing the individual and small business insurance marketplaces set up under the Affordable Care Act (“ACA”). According to the proposed rule, the marketplaces “have recently been threatened by issuer exit and increasing rates in many geographic areas.” The …
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OIG Rejects Laboratory’s Offer to Provide Free Labeling to Dialysis Facilities
March 10, 2017 | Health Services
The U.S. Office of the Inspector General (“OIG”) recently issued Advisory Opinion No. 16-12 (the “Opinion”) regarding a proposed arrangement between a laboratory and a dialysis facility. Briefly stated, the laboratory proposed to offer the dialysis facility free labeling of test tubes and specimen collection containers, a task which is typically performed by the dialysis …
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CMS and OMIG Provide Guidance on Combating Opioid Epidemic
February 15, 2017 | Health Services
The Healthcare Fraud Prevention Partnership (“HFPP”), in conjunction with the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services (“CMS”), has recently issued a White Paper that outlines recommended actions to reduce opioid misuse and opioid-use disorders (“OUDs”) in the United States. It has been estimated that prescription opioid …
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HHS Finalizes Amendments to Confidentiality Rules for Alcohol and Drug Abuse Patients
February 15, 2017 | Health Services
For the first time in thirty years, the Substance Abuse and Mental Health Services Administration (“SAMHSA”), a branch of the U.S. Department of Health and Human Services (“HHS”), issued a final rule amending 42 CFR Part 2 (commonly referred to as “Part 2”) which governs the confidentiality of alcohol and drug abuse patient records. The …
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Kutner quoted in Part B News
February 6, 2017 | Health Services
Christopher J. Kutner was quoted in a Part B News article entitled, “Beyond QPP: Check Your Readiness for Insurer-Based Physician Incentive Programs.” Regarding non-federal physician incentive programs, Chris said they are about shifting to value-based payment options, so be sure you’re in a position to take it on. “Even without downside risk, you have to think about …
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New York Passes New Law to Allow Outpatient Clinics and ASCs to Provide Off-Site Services
January 24, 2017 | Health Services
New York Governor, Andrew Cuomo, has signed a new legislation that may pave the way for outpatient clinics and diagnostic and treatment centers, which includes ambulatory surgery centers (“ASCs”), to provide primary care services to their patients off-site under limited circumstances. The new law, codified in the Public Health Law § 2803(11), requires that the …
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OIG Releases Work Plan for 2017
January 24, 2017 | Health Services
The Department of Health and Human Services, Office of Inspector General (“OIG”) has released its Work Plan for Fiscal Year 2017 (the “Plan”). The Plan, available through the OIG website, summarizes new and ongoing audits, investigations and evaluations that OIG will prioritize in the upcoming year. Some of the new initiatives that OIG intends to …
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OIG Adds New Safe Harbor Protections in 2017
January 24, 2017 | Health Services
In December 2016, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services amended existing safe harbors and issued a number of new safe harbors to   protect certain business practices and arrangements of doctors, hospitals, and pharmacies from sanctions under the anti-kickback statute (42 U.S.C. § 1320a-7b(b)). Additionally, OIG amended …
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The Future of the Affordable Care Act
January 23, 2017 | Health Services
Since its enactment six years ago, the Patient Protection and Affordable Care Act (the ACA) has faced numerous challenges from Republicans attempting to repeal the law. Though previous efforts, through both legislation and litigation, have been unsuccessful, the election of Donald Trump and a Republican-controlled Congress likely portends at least a partial repeal of the …
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Five Essential Questions To Mitigate Corporate Compliance Risk
November 18, 2016 | Health Services | Compliance Investigations & White Collar
In an increasingly intense and unforgiving regulatory environment, all healthcare organizations — from small physician practice groups to large health systems — must closely scrutinize areas where they may be vulnerable to fraud and abuse allegations. Corporate compliance programs are useful in this effort, but only if they are well-constructed and aggressively implemented, not merely …
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The Future of the Affordable Care Act
November 11, 2016 | Health Services
Since its enactment six years ago, the Patient Protection and Affordable Care Act (the “ACA”) has faced numerous challenges from Republicans attempting to repeal the law. Though previous efforts, through both legislation and litigation, have been unsuccessful, the election of Donald Trump and a Republican-controlled Congress likely portends at least a partial repeal of the …
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Reminder to New York Medicaid Providers: Certification of Compliance Program Must be Completed by December 31, 2016
November 11, 2016 | Health Services
New York State Medicaid providers who claim, order or receive at least $500,000 in any consecutive 12-month period from the Medicaid Program are required to implement a compliance program aimed at detecting and preventing Medicaid fraud, waste and abuse. This requirement also applies to third party billing companies that bill or receive the threshold amount …
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Safe Harbor, Safe Passage Under the Anti-Kickback Statute
November 11, 2016 | Health Services
For providers contemplating a business arrangement with a potential referral source for items or services reimbursable under a federal health care program, fitting that arrangement within a recognized safe harbor under the Anti-Kickback Statute (“AKS”) is the “holy grail,” for it ensures that the arrangement will be immunized against civil and criminal enforcement actions.  And …
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CMS Offers Flexibility for Physician Participation in MACRA
October 14, 2016 | Health Services
Pursuant to the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), in April 2016, the U.S. Department of Health and Human Services issued a proposed rule that will require physicians who receive Medicare payments to participate in one of two payment programs: (1) the Merit-Based Incentive System (“MIPS”); or (2) the Alternative Payment Models …
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Reminder: Health Care Providers Must Post Nondiscrimination Notices by October 16, 2016
October 14, 2016 | Health Services
Pursuant to a final rule issued by the U.S. Department of Health and Human Services (the “HHS Rule”), certain health care providers covered by Section 1557 of the Affordable Care Act (“Section 1557”) will be required to post nondiscrimination notices and taglines by October 16, 2016. Section 1557 prohibits discrimination on the basis of race, …
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Caffeine’s Rise to Controversy and Popularity in Helping Consumers Attain Energy
September 29, 2016 | Health Services | Compliance Investigations & White Collar
Caffeine seems to have been around forever. I do not remember my first cup of coffee or my first can of cola, but I do remember the over-the-counter (OTC) stimulant drug products containing 200 mg of caffeine that were an absolute necessity for most of my classmates to survive freshman year of college and first …
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HIPAA Phase 2 Audit Protocol: Would Your Client Pass the Test?
September 22, 2016 | Health Services
Benjamin Malerba’s and Ada Kozicz’s article entitled HIPAA Phase 2 Audit Protocol: Would Your Client Pass the Test was published by the American Bar Association. The United States Department of Health and Human Services’ Office for Civil Rights (OCR) recently released its protocol for the next phase of audits that will be conducted throughout the second …
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Ransomware: A Threat to Any Business, Large or Small
September 20, 2016 | Health Services | Compliance Investigations & White Collar
Marc Ullman’s article entitled, “Ransomware: A Threat to Any Business, Large or Small,” was recently published by Natural Products Insider. According to a recent report by Malwarebytes, an anti-malware software company, a whopping 39 percent of the 540 companies from the United States, Canada, Germany and the United Kingdom surveyed in June 2016 suffered some form …
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